3M CANADA September 26, 2018 · September 26, 2018. TIME EVENT 7:45 –8:15 Breakfast/ Registration...

Preview:

Click to see full reader

Citation preview

Toronto Canadian Food Safety Symposium 20183M CANADA

September 26 2018

TIME EVENT

745 ndash 815 Breakfast Registration

820 ndash 830 Introduction

830 ndash 930 Speaker 1 Ken Davenport

930 ndash 1000 Speaker 2 Andreacute Cocircteacute

1000 ndash 1015 Break

1015 ndash 1045 Speaker 3 Wei Que

1045 ndash 1230 Speaker 4 Dr Worobo

1230 ndash 130 Lunch

130 ndash 300 Round Table

WRITE DOWN QUESTION THROUGHOUT THE DAY TO ASK SPEAKERS

3M STAFF WILL BE

WEARING RED BELTS

WASHROOMSBESIDE ELEVATORLEFT

ADDITIONAL IN RESTAURANT

BEVERAGES amp SNACKS WILL BE

PROVIDED AT BREAK TIMES

LUNCH VISIT ALL 4 TABLES WITH YOUR

PUNCH CARD FOR A CHANCE TO

WIN

PLEASE TURN YOUR PHONES OFF

IMPORTANT NOTES

KEYNOTE SPEAKERS

DR KEN DAVENPORTbull Undergraduate degree in Chemistry from Spring Arbor

University

bull MBA from the University of Minnesota

bull PhD from the Department of Biochemistry at Rice University

bull 15+ years of experience in the food industry and 20 years experience with rapid method development and applications

bull Group leader for new technologies for the detection of chemical and microbial contaminants in food and the food manufacturing environment

Allergens amp HACCP

Humans love and need food

Food allergy prevalence

bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population

bull 4-8 in infant and young children population

bull Cowrsquos milk egg and peanuts among the most common allergenic foods

can change depending of region and dietary patterns

bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries

9 All Rights Reserved11 December 2018copy 3M

What is an allergen

10 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Micro-nutrients

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

11 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Not susceptible population

Micro-nutrients

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

TIME EVENT

745 ndash 815 Breakfast Registration

820 ndash 830 Introduction

830 ndash 930 Speaker 1 Ken Davenport

930 ndash 1000 Speaker 2 Andreacute Cocircteacute

1000 ndash 1015 Break

1015 ndash 1045 Speaker 3 Wei Que

1045 ndash 1230 Speaker 4 Dr Worobo

1230 ndash 130 Lunch

130 ndash 300 Round Table

WRITE DOWN QUESTION THROUGHOUT THE DAY TO ASK SPEAKERS

3M STAFF WILL BE

WEARING RED BELTS

WASHROOMSBESIDE ELEVATORLEFT

ADDITIONAL IN RESTAURANT

BEVERAGES amp SNACKS WILL BE

PROVIDED AT BREAK TIMES

LUNCH VISIT ALL 4 TABLES WITH YOUR

PUNCH CARD FOR A CHANCE TO

WIN

PLEASE TURN YOUR PHONES OFF

IMPORTANT NOTES

KEYNOTE SPEAKERS

DR KEN DAVENPORTbull Undergraduate degree in Chemistry from Spring Arbor

University

bull MBA from the University of Minnesota

bull PhD from the Department of Biochemistry at Rice University

bull 15+ years of experience in the food industry and 20 years experience with rapid method development and applications

bull Group leader for new technologies for the detection of chemical and microbial contaminants in food and the food manufacturing environment

Allergens amp HACCP

Humans love and need food

Food allergy prevalence

bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population

bull 4-8 in infant and young children population

bull Cowrsquos milk egg and peanuts among the most common allergenic foods

can change depending of region and dietary patterns

bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries

9 All Rights Reserved11 December 2018copy 3M

What is an allergen

10 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Micro-nutrients

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

11 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Not susceptible population

Micro-nutrients

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

WRITE DOWN QUESTION THROUGHOUT THE DAY TO ASK SPEAKERS

3M STAFF WILL BE

WEARING RED BELTS

WASHROOMSBESIDE ELEVATORLEFT

ADDITIONAL IN RESTAURANT

BEVERAGES amp SNACKS WILL BE

PROVIDED AT BREAK TIMES

LUNCH VISIT ALL 4 TABLES WITH YOUR

PUNCH CARD FOR A CHANCE TO

WIN

PLEASE TURN YOUR PHONES OFF

IMPORTANT NOTES

KEYNOTE SPEAKERS

DR KEN DAVENPORTbull Undergraduate degree in Chemistry from Spring Arbor

University

bull MBA from the University of Minnesota

bull PhD from the Department of Biochemistry at Rice University

bull 15+ years of experience in the food industry and 20 years experience with rapid method development and applications

bull Group leader for new technologies for the detection of chemical and microbial contaminants in food and the food manufacturing environment

Allergens amp HACCP

Humans love and need food

Food allergy prevalence

bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population

bull 4-8 in infant and young children population

bull Cowrsquos milk egg and peanuts among the most common allergenic foods

can change depending of region and dietary patterns

bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries

9 All Rights Reserved11 December 2018copy 3M

What is an allergen

10 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Micro-nutrients

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

11 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Not susceptible population

Micro-nutrients

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

KEYNOTE SPEAKERS

DR KEN DAVENPORTbull Undergraduate degree in Chemistry from Spring Arbor

University

bull MBA from the University of Minnesota

bull PhD from the Department of Biochemistry at Rice University

bull 15+ years of experience in the food industry and 20 years experience with rapid method development and applications

bull Group leader for new technologies for the detection of chemical and microbial contaminants in food and the food manufacturing environment

Allergens amp HACCP

Humans love and need food

Food allergy prevalence

bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population

bull 4-8 in infant and young children population

bull Cowrsquos milk egg and peanuts among the most common allergenic foods

can change depending of region and dietary patterns

bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries

9 All Rights Reserved11 December 2018copy 3M

What is an allergen

10 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Micro-nutrients

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

11 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Not susceptible population

Micro-nutrients

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

DR KEN DAVENPORTbull Undergraduate degree in Chemistry from Spring Arbor

University

bull MBA from the University of Minnesota

bull PhD from the Department of Biochemistry at Rice University

bull 15+ years of experience in the food industry and 20 years experience with rapid method development and applications

bull Group leader for new technologies for the detection of chemical and microbial contaminants in food and the food manufacturing environment

Allergens amp HACCP

Humans love and need food

Food allergy prevalence

bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population

bull 4-8 in infant and young children population

bull Cowrsquos milk egg and peanuts among the most common allergenic foods

can change depending of region and dietary patterns

bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries

9 All Rights Reserved11 December 2018copy 3M

What is an allergen

10 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Micro-nutrients

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

11 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Not susceptible population

Micro-nutrients

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Allergens amp HACCP

Humans love and need food

Food allergy prevalence

bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population

bull 4-8 in infant and young children population

bull Cowrsquos milk egg and peanuts among the most common allergenic foods

can change depending of region and dietary patterns

bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries

9 All Rights Reserved11 December 2018copy 3M

What is an allergen

10 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Micro-nutrients

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

11 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Not susceptible population

Micro-nutrients

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Humans love and need food

Food allergy prevalence

bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population

bull 4-8 in infant and young children population

bull Cowrsquos milk egg and peanuts among the most common allergenic foods

can change depending of region and dietary patterns

bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries

9 All Rights Reserved11 December 2018copy 3M

What is an allergen

10 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Micro-nutrients

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

11 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Not susceptible population

Micro-nutrients

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Food allergy prevalence

bull It is estimated that more than 200-250 million people may have a food allergy globallybull 1-2 in adult population

bull 4-8 in infant and young children population

bull Cowrsquos milk egg and peanuts among the most common allergenic foods

can change depending of region and dietary patterns

bull More prevalent in developed countries but prevalence is increasing in both developed and developing countries

9 All Rights Reserved11 December 2018copy 3M

What is an allergen

10 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Micro-nutrients

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

11 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Not susceptible population

Micro-nutrients

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

9 All Rights Reserved11 December 2018copy 3M

What is an allergen

10 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Micro-nutrients

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

11 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Not susceptible population

Micro-nutrients

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

10 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Micro-nutrients

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

11 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Not susceptible population

Micro-nutrients

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

11 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Not susceptible population

Micro-nutrients

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

12 All Rights Reserved11 December 2018copy 3M

What is an allergen

The composition of most foods includes four elemental components

Carbo-hydrates

Lipids

Proteins

Some people will have immune systems that will mistake some food proteins for

infectious agents and aggressively attack the proteins

Allergen

Allergen

Not susceptible population

Allergic reactionSusceptible population

Micro-nutrients

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

13 All Rights Reserved11 December 2018copy 3M

An allergy is different from a food sensitivity or allergy-like intoxications

Adverse reaction to food

IgE mediated

Food allergy

Non- IgE mediated

Allergy-like intoxication

Ingestion of histamine produced in foodScombroid fish

poisoning

Senstivity

Sulfite inducedasthma

Strawbery or chocolate induced

histamine

Lactose intolerance

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

14 All Rights Reserved11 December 2018copy 3M

What IS food allergy

Food allergy symptoms

Gastro-intestinalVomitingDiarrheaNausea

Abdominal cramps

RespiratoryAsthma

Wheezingrhinitis

CutaneousUrticaria (hives)

EczemaDermatitis

Rashangioedema

Extreme symptomsAnaphylactic shock

HypotensionSwelling of tongueLaryngeal edema

OAS Oral allergic syndrome mild reaction located in oropharyngeal area of mouth and throat (urticaria and angioderma) most common symptoms to food allergy

Anaphylactic shock and asthma are the most common causes of death in the occasional fatalities associated to food allergies

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

15 All Rights Reserved11 December 2018copy 3M

What is NOT a food allergy

Lactose Intolerance

ldquoAllergicrdquo to Sulfite in Wine

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

16 All Rights Reserved11 December 2018copy 3M

What foods are most often related to food allergies

Additional

bull Lupinesbull Sesamebull Mustardbull Celerybull Rosacea fruits

The big 8 Plus additional ones depending on country and region

True answer Many food proteins may be allergenic but these are under strict labelling control in the US Canada EU and many other countries

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

17 All Rights Reserved11 December 2018copy 3MhttpsfarrpunledudocumentsRegulatoryInternational20Allergens209-21-17pdf

What foods are most often regulated as allergens

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

18 All Rights Reserved11 December 2018copy 3M

Preventing food allergies in the human population

ALLERGEN CONTROLSegregation

Prevent cross-contactLABELLING

Allergen free

Allergen content

May contain

statements

FSMAPreventive

controls

HACCPPreventive

controls

GMPsPreventive

controls

Environmental monitoring

Preventive controls

CleaningPreventive

controls

Health professionals regulators allergic patients or their caretakers also hold responsibility to prevent food allergy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

19

3M Health Care AcademySM

HACCP Overview

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

HACCP

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

20

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

21

3M Health Care AcademySM

Introduction to HARPC

The US Food Safety Modernization Act (FSMA) was signed into law Jan 4 2011 changed the

paradigm for food safety regulations and FDA inspections for the US

Requires a written Food Safety Plan containing

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification program

- Written recall plan

Hazard Analysis and Risk-based Preventative Controls

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

22

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

23

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

24

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

25

3M Health Care AcademySM

Risk-Based Preventative Controls

- ProcessProduct parameter-based controls (ex Cookingheating acidifying irradiating or

refrigerating)

- Maximum andor minimum values for the hazard to prevent the hazard occurring

- Process controls must include procedures practices and processes performed on food

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

26

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

The leading cause of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

27

3M Health Care AcademySM

Why the new ldquopreventative controlsrdquo

- Food allergen controls must be explicitly identified

- Labeling of the finished food to ensure compliance

- Sanitation controls

Essentially all food safety outbreaks in the last decade have been due to a lack of sanitation or other ldquoprerequisite programsrdquo rather than failures of CCPs

The majority of recalls are due to undeclared allergens on the label- Mis-labeling- Cross-contact

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

28

3M Health Care AcademySM

Comparison of HARPC and HACCP

1 Conduct Hazard Analysis

2 Identify CCPs

3 Establish Critical Limits

4 Establish Monitoring Actions

5 Establish corrective Actions

6 Establish Verification Procedures

7 Establish a Record-Keeping System

- Written Hazard Analysis

- Written and validated preventative controls

- Written corrective action procedures

- Written verification procedures

- Written supplier approval and verification

program

- Written recall plan

HACCP HARPC

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

29 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

30 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

Primary to minimally processed ingredients

Specification about residual allergen content

Example Codex Standard for wheat allow up to 3 other grains

Raw material segregation (ierice flour from wheat flour)

Dedicated or Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION CLEANING VERIFICATION

Confirmation you have the right productRMs

Test ldquofirst off the linerdquo

Test ldquorepresentative samplerdquo for allergens

bull Often quantitativebull Often 3rd party lab

Product Testing Product

Testing

Environmental testing

Qualitative Product Testing

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

31 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

32 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

THIS STEP IS DONE EVEN BEFORE IMPLEMENTING A MANUFACTURING PROCESS

bull Shared production linesbull Beverage containing cowrsquos milkbull Beverage labeled as dairy free or that milk is not in the ingredient label

Support risk assessment and risk

management activities

Usually a quantitative analysis is required

ELISA

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

33 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

34 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VALIDATION

Usually a quantitative analysis is required

ELISA

Validation in the allergen world refers to a science based approach study that evaluates the efficacy of a cleaning process to remove allergenic food residues

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

35 All Rights Reserved11 December 2018copy 3M

Allergen control during manufacturing VERIFICATION

Once a cleaning procedure is in place after thorough VALIDATION then regular VERIFICATION can be used as a strategy to demonstrate that the implemented cleaning process is effective

a Rapid allergen testb Rapid protein testc ATPd Visual inspection

Allergen testing can be (should be) part of the environmental monitoring programs

Support risk management activities

Usually a qualitative analysis is required

Lateral Flow Devices

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

36 All Rights Reserved11 December 2018copy 3M

Allergen testing

Quantitative

Qualitative

Requires to know concentration of allergen

protein in the food

Presenceabsence is sufficient to trigger corrective actions

(at a certain level of detection)

Final product

Rinse waterCIP

CIP Clean In Place final rinse water

Swabs

Most common during process

VALIDATION

Raw material

Final product

Rinse waterCIP

SwabsRaw

material

In many cases through third party reference or service

lab

Most common during process

VERIFICATION

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

37 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein ELISA KitsEnzyme-Linked Immuno-Sorbant Assay

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

ELISA (Enzyme Linked Immuno-Sorbant Assay)

Antibody based method

Detect presence of protein by making an antibody

sandwich amp detecting a marker (enzyme) linked to one of

the antibodies (conjugated antibody)

YYYYYY YYYYYY

Positive Negative

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

ELISA tests ndash what the results look like

Negative

Positive

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

40 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

41 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsResults

Positves results may appear as fast as in 5 min

Once is positive stays positive

A negative result should be confirmed at 11 + 1 min

After 12 min the strip is not valid

The intensity of the band is irrelevant a faint line is as positive as a strong line

(Gluten does not have an H line)

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Lateral Flow ndash Positive Test

YYY YYY

Test Hook Control

Y

Allergen Protein

Other Protein

Antibody with Gold Bead

Capture Antibody

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Lateral Flow ndash Negative Test

YYY YYY

Test Hook Control

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Lateral Flow ndashControl Lines - denatured

YYY YYY

Test Hook Control

Ex pH 3DetergentAlcohol

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Lateral Flow ndash Hook Line for Overload

YYY YYY

Test Hook Control

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

46 All Rights Reserved11 December 2018copy 3M

Allergen control in food manufacturing operations

Raw material selection and specification

Manufacturing operations Finished Product Testing

bull Primary to minimally processed ingredients

bull Specification about residual allergen content

bull Example Codex Standard for wheat allow up to 3 other grains

bull Codex Standard for maize allows up to 2 of other grants

bull Raw material segregation (ie rice flour from wheat flour)

bull Shared manufacturing lines

Ex Gluten free pasta and wheat pasta should avoid cross-contact

CLEANING VALIDATION amp VERIFICATION

Confirmation you have the right productRMs

bull Test ldquofirst off the linerdquo

bull Test ldquorepresentative samplerdquo for allergensbull Often quantitativebull Often 3rd party lab

Product Testing

Product Testing

Lateral Flow

Qualitative Product Testing -

Lateral Flow

Generally ELISA (could use Lat

Flow)

ELISA

ELISA

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

47 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

CleaningCleaning

Verification

Production Start

ldquoFormula Verificationrdquo

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

48 All Rights Reserved11 December 2018copy 3M

3M Allergen Protein Rapid KitsldquoLateral Flow Devicesrdquo - LFDs

SOLID FOOD

LIQUID FOOD

SWABSCIP

rinse water

3M LFD Differentiation

3M LFD Differentiation

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

49 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Processing can either increase or reduce allergenic effect no guarantee

Heat Treated roasting

pasteurization cooking baking

bull Protein from raw peanutsbull Protein from raw milkbull Protein from wheat flour

bull Protein from roasted peanutsbull Protein from UHT milkbull Protein from wheat flour in a fully baked

cake

This schematics are just for representation processed and unprocessed proteins are not necessarily linear they can also be folded and have changes in conformation

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

50 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Assays with monoclonal antibodies can work very well some assays for specificity will require a monoclonal

Antibodies raised only against unprocessed proteins recognize a

particular epitope

Antibodies may be unable to bind to the

processed protein

No epitope recognition

Heat Treated roasting

pasteurization cooking baking

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

51 All Rights Reserved11 December 2018copy 3M

Immunoassays in food testing Impact of food processing

Polyclonal antibodies recognize several epitopes

Even if both antibodies bind to fragments because the fragments

arenrsquot connected you get a FALSE-Negative Test Result

in ELISA and LFDs

Protein Break-down Process

FermentationEnzymatic Digestion

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

THANK YOU

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

DR RANDY WOROBObull Professor of Food Microbiology at

Cornell University

bull Research focused on non-thermal processing alternatives for juice and beverages microbial spoilage of foods and beverages pathogen transmission and survival on fruits and vegetables

bull Extensive knowledge in winery beverage and food processing plant sanitation and has worked with various industries on safety and sanitation programs

bull Member of the FDA Juice HACCP Curriculum Committee a certified Juice HACCP Train the Trainer and Food Safety Preventive Controls Trainer

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Controlling for Food Spoilage Using Environmental Monitoring

Presented by

3M Food Safety

Dr Randy WoroboProfessor of Food Microbiology Department of Food ScienceCornell University

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Where does microbial contamination come from in a food production facility

Animals

Humans

Inanimate Objects

(food contact surfaces)

Rodents amp Pests

Environmental

FOOD

(Modified from Beuchat)

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Controlling Microbial Contamination

bull Sanitation programs are needed to prevent pathogen and spoilage microorganisms in food production facilities

bull Hygiene monitoring is crucial to assess the effectiveness of your cleaning and sanitation programs

bull Environmental monitoring is essential to identify pathogen and spoilage harborage sites

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Goals of a Microbial Environmental Testing Program

bull Verification samplingrdquo Verify food safety procedures such asbull Cleaningbull Sanitationbull Sanitary equipment designbull Hygienic zoning

bull ldquoPreventive Control Investigationrdquobull Identify problem areas harboring pathogen sources (ldquonichesrdquo) and

locate potential contamination sourcesbull Characterize transmission pathwaysbull Validate preventive controls (eg sanitation procedures for a specific

piece of equipment) (ldquoSeek and destroy investigationrdquo)bull Early Warning that will predict potential loss of control

(ldquoIndicator sitesrdquo)bull Indicators sites are typically in zone 3 and 4

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Seek and Destroy

bull Systematic approach to finding sites of persistent growth (niches) in food processing plantsbull Environmental sampling with follow up on every positive sample

bull Goal is to either eradicate or mitigate effects of nichesbull Seek and Destroy can be applied to specific equipment (eg

new equipment qualification) or the facility as a whole

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Where to Test

bull Food contact surfacesbull Food contact surface positives may have to be followed up with

finished product testing

bull Non-food contact surfacesbull Sites in coolers (floors walls cooler coils condensate collectors etc)

bull Tubs conveyances underneath tables

bull Floors floor mats walls amp drains in production areas

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Where to Test ndash The Zone Concept

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Where to Test

bull Nichesbull Hollow rollers table legs etc floor wall

junctures floor cracks difficult to clean areas seals on doors etc

bull Sampling of niches more likely to identify source

bull Transfer pointsbull Hands door handles

bull Sampling of transfer points requires follow up to identify source

bull Some areas could be bothbull Key boards

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Other Sampling Considerations

bull Must select samples to find positivesbull Subtleties of sampling are much more important with

environmental samples as compared to finished product samples

bull Need to set up a system that encourages collection of samples that yield positive results

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Hygiene and environmental monitoring and management programs

bull Monitor for effectivenessbull Conduct planned sequence of observations or measurements to assess

sanitary conditions

bull Document to meet regulatory requirements

bull Manage for efficiencybull Review of data collected to identify potential areas of improvement

bull Review of data collected to identify and prevent future issues

Verifying Effectiveness of Cleaning and Monitoring the Environment

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Measuring the Effectiveness of Cleaning and Sanitation

All have their place in a robust hygiene

monitoring program

Visual inspection

ATP bioluminescence

Traditional microbiology

(swab amp plate)

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Measuring the Effectiveness of Cleaning and Sanitation

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

ATP is the ldquoenergy currencyrdquo molecule of all living organisms

What is ATP

Adenosine

Phosphates

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Sources of ATP

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

How ATP Bioluminescence Works

ATP = Adenosine TriphosphateThe ldquoenergy currencyrdquo molecule

of all living organisms

Increasein organisms

or organic residues

Increase in ATP levels+

Luciferinluciferase

Increasein light (RLU)

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Simple Relationship

Increase in organic residues

Increase in ATP levels

Increase in light (RLU)

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Benefits of Using ATP as a ldquoRiskrdquo Indicator

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Survey of 8 Beverage Facilities

1 Both cleaning and sanitation

practices and testing are not

only for FCS but also for non-

FCS

2 Fabrication of the surface is

important in terms of its clean-

ability

3 Continual sanitation operations

during production reduce

environmental contamination

0

100

200

300

400

500

600

700

800

900

1000

Drain Floor Container Bottling line Clean StainlessSteel Tank

RL

Us

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

1 Identify testing locations

2 Determine the testing frequency

3 Analyze the data

4 Implement short-term corrective actions

5 Perform root cause analysis

Guidance on Building a Hygiene Management Program

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Environmental Monitoring

bull Environmental monitoring should be an integrated approachbull Hygiene monitoring (ATP testing)

bull Indicator organism testing

bull Spoilage organism testing

bull Pathogen testing

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Production Line

ATP Testing

Forklift Cart

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

MicroIndicator Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Pathogen Testing

Facility Sampling Guidance

Packaging WarehouseRM

Warehouse

Finished Goods

Production Line

Forklift Cart

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

bull Risk Analysis 101

bull How significant is the Hazard

bull How close is the surface to the food

bull What is the Probability the Hazard will occur

bull How hard is it to clean the surface

Test Point Selection Process

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Low Medium High

High

Medium

Low

Probability

Color = risk level

Test Point Selection Process

How Close to the Food

Zone 1 Direct Contact

Zone 2 Indirect Contact

Zone 3 Close Proximity

Zone 4 General Area

How close to food How hard to clean

Ha

zard

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Mixer

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Wall

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Unlikely

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Probe

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Possible

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Drain

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard High impactProbability Probable

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Outside Hull

Example Jacketed Mixer Kettle

Low Medium High

High

Medium

Low

Probability

Haz

ard

Hazard Moderate impactProbability Unlikely

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Weight

Blade

Tray

Collection Pan

Collection Side

Slice Thickness Knob

Slicer Handle

Example Meat Slicer

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Low Medium High

High

Medium

Low

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Find trends in the data trends in the plant

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Immediately identify cost savings

Identify potential increased costs

bull Visualize trends

bull By sample point

bull By particular day or week

bull Easy to interpret

bull Align resources

bull Justify resources

bull Existing and new

Ranking and Trending Reports

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Making the Most From your Data

Coliform Trends from 2006 - 2008

90

92

94

96

98

100Ja

n-0

6

Ma

r-0

6

Ma

y-0

6

Ju

l-0

6

Se

p-0

6

No

v-0

6

Ja

n-0

7

Ma

r-0

7

Ma

y-0

7

Ju

l-0

7

Se

p-0

7

No

v-0

7

Ja

n-0

8

Ma

r-0

8

Ma

y-0

8

Time (months)

o

f c

olifo

rm

s lt

1 c

fum

L

Test Point Trend 2006-08

0

20

40

60

80

100

120

140

160

802

06

130306

130606

230806

311006

170307

110707

180707

250707

310707

908

07

240807

300807

709

07

261107

301107

712

07

Time

RL

U Pass Limit

Result

Introduction of ATP

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Striving for Continual Improvement

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

⦁ Measured Aerobic Count in finished product

⦁ AC target is lt10 x 105 CFUg

bull Many many samples had been failing the AC target levels

Food Manufacturer Case Study 1

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9

SAMPLE NUMBER

CF

UG

1901

2104

Provided by 3M Food Safety

Food Manufacturer Case Study

This graph shows the microbiology (total aerobic count) data for finished product testing

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

APC GRAPH CORN 2008

0

50000

100000

150000

200000

250000

300000

350000

1

25

49

73

97

12

1

14

5

16

9

19

3

21

7

24

1

26

5

28

9

31

3

33

7

36

1

38

5

40

9

43

3

45

7

48

1

50

5

52

9

55

3

57

7

60

1

62

5

64

9

67

3

69

7

72

1

74

5

76

9

79

3

81

7

84

1

86

5

88

9SAMPLE NUMBER

CF

UG

1901

2104

Introduction of ATP testing

2009 corn season APC results

0

50000

100000

150000

200000

250000

300000

350000

1

19

37

55

73

91

10

9

12

7

14

5

16

3

18

1

19

9

21

7

23

5

25

3

27

1

28

9

30

7

32

5

34

3

36

1

37

9

39

7

41

5

43

3

45

1

46

9

48

7

50

5

52

3

54

1

55

9

57

7

59

5

61

3

63

1

64

9

66

7

68

5

sample number

AP

C

spec limit

280109020209

1804

Food Manufacturer Case Study

Significant improvement in finished product quality almost immediately

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

⦁ Additional microbiological testing reveals Asaia spp

⦁ Acetic Acid Bacterium

⦁ Cleaning amp sanitation records (CIP amp COP) acceptable

Food Manufacturer Case Study 2

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Identifying the Contamination Source

0

05

1

15

2

25

3

35Ingredients

Well water

Mixing tank

Pasteurized Bulk HoldingTank

Filler

Log

CFU

ml o

r g

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Identifying the Contamination Source ndash ATP swabbing

0

500

1000

1500

2000

2500

3000

3500

4000

4500Water line to mixing tank

Mixing tank

Filler

Pasteurized Bulk HoldingTank

Line to pasteurizer

RLU

Val

ue

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

⦁ Line to filler from pasteurized bulk holding tank

was not in CIP loop

⦁ Sanitizer used was peroxyacetic acid

⦁ Asaia is aciduric so acid-based sanitizers are less

effective

⦁ Line to filler was non-sanitary welds amp corroded

Root Cause Analysis

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

⦁ Filler line from pasteurized bulk holding tank

replaced with new stainless steel pipe fabricated

with sanitary grade welds and included in CIP

loop

⦁ Chlorine based sanitizer used throughout the

facility

Corrective Procedures

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

⦁ Tofu manufacturer

⦁ Vacuum packaged refrigerated pasteurized

product

⦁ Customer complaints of off flavors and odors

⦁ Elevated finished product counts on APC

⦁ Pasteurization records indicate critical limits are

being met

Food Manufacturer Case Study 3

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

⦁ Gram negative spoilage organism identified (heat

sensitive

⦁ Packaging integrity confirmed

⦁ Deep cleaning of equipment reduced spoilage

incidence but gradually increased over time

Food Manufacturer Case Study 3

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Identifying the Spoilage Source

0

1

2

3

4

5

6

7Formed tofu

cut tofu

Cooling tank

Vacuum packagedunpasteurized

Pasteurized finishedproduct

Log

CFU

ml o

r g

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Cooling Tank amp Conveyor ndash ATP amp Micro Swabbing

Problem spots

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

RCA

⦁ Conveyortank not sanitary design amp poor

cleaning

Corrections

⦁ Sanitary design conveyor for improved cleaning

Root Cause Analysis amp Corrections

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

bull Cleaning and sanitation regime are essential to ensuring the

safety and quality of your hygiene management program

bull ATP luminescence testing can provide a rapid evaluation of the

cleaning and sanitation regimes for all contact surfaces

bull Can be used to identify sources for microbial contamination

(safety amp quality) that may be from practices and the facility

bull As part of a routine environmentally monitoring program it can

identify trends and prevent potential problems

Key Points to Consider

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Thank youThank You

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

LUNCH

bull 1230 ndash 130

Donrsquot forget to visit our booths for your chance to win

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Add a Slide Title - 5THANK YOU

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

HEALTH CARE ACADEMY

VISIT FOR MORE EDUCATIONAL

CONTENT AND HOW-TOrsquoS

3mcahealthcareacademy

Recommended

8' Ceiling Speaker System 100w - products.electrovoice.com
Documents
Friday, November 30, 2018 - Sunnybrook Hospital€¦ · Revolutionizing Healthcare’s Future Friday, November 30, 2018 ... Education Conference Schedule 6 Keynote Speaker 8 Afternoon
Documents
PRESIDENT’S MESSAGE · 3 AAUW Dinner Meeting: May 15, 2019, 5:30-8:30 PM, Parasol Building This will be a branch business meeting with no guest speaker
Documents
eC omerc e t u a l Pr p r eCommerce & IP Law Seminar ...€¦ · SCHEDULE 8:00 - 8:30 Registration and Welcome 8:30 - 9:30 Mobile Application Legal Issues Speaker: John Goodhue, Goodhue,
Documents
PRELIMINARY AGENDA · 2018. 11. 15. · PRELIMINARY AGENDA. Agenda - Day 1 Time Name of Speaker/Company 8:30 AM - 8:35 AM MSTA CANADA - Ryan McEachern, Managing Director 8:35 AM -
Documents
Next Meeting: Monday September 21st 7:30 p.m. Speaker ... Rose...1 Next Meeting: Monday September 21st 7:30 p.m. B.Y.O. BBQ 6:30 p.m. Speaker: Alex Comino ‘bloodhound’ ‘Fire
Documents
DATE EVENT/SPEAKER CONTENT LOCATION/SPONSORoct 1, 2015 full day 8:00 am - 4:00 pm date event/speaker content location/sponsor sep 13, 2019 full day 8:30 am - 12:45 pm bbq at 1pm -
Documents
Ribbon Tweeter - Raidho · Ribbon Tweeter FTT75-30-8 The Raidho Ribbon tweeter FTT75-30-8 is a unique sealed ribbon tweeter. ... the speaker system. 2 . Ribbon Tweeter
Documents
With Guest Speaker · With Guest Speaker The Livingston Manor Community Garden at Pearl Street An edible and educational garden. WHEN Thursday, July 30, 2015 6:30 - 7:30 p.m. WHERE
Documents
2020 Annual Meeting - MemberClicks · 7:00 am Membership Breakfast 8:00 am Division I Meeting & Speaker Alan Beaulieu 9:30 am Division II Update 10:00 am Division III Meeting & Speaker
Documents
Volcano monitoring intro.pptvhub.org/resources/2029/download/Varley_Introduction_COV7_Work… · Schedule Time Topic Speaker 8:30 Introduction to the workshop Jeff Johnson, Nick Varley
Documents
Ceiling Speaker Installation Manual · 2020. 11. 30. · 5 Ceiling Speaker Installation Manual Speaker placement Ceiling speakers (IC62, IC64, IC66, IC82, IC86) Standard Adept Audio
Documents
SHort-Range Independent Microrobotic Platforms (SHRIMP ......SHRIMP Proposers’ Day Agenda Time Topic Speaker Duration 8:30 Registration Sign-In - 0:30 9:00 Logistics & Security PSR/PSO
Documents
Mill Speaker Notes€¦ · Презентация PowerPoint Author: Dmitri Created Date: 10/17/2012 8:30:28 AM
Documents
Wednesday, February 8, 2017 6:30 PM - 8:30 PM Featured Speaker · 2019. 5. 31. · INC-3624. Case-Based Discussion Recognizing Resistance to and Intolerance of Hydroxyurea in Polycythemia
Documents
The Deeper Work 2 Kings 5:1, 8-17 August 30, 2015 © August 30, 2015 Guest Speaker: Pastor Ed Salas
Documents
PF-20T and PF-50T · 2 Daisy Chaining 8 Speaker Cabinet A 8 or 4 Speaker Cabinet 8 Speaker Cabinet B PF-20T / PF-50T PF-20T / PF-50T PF-20T / PF-50T Standard Setup
Documents
8” - 40W Coaxial Ceiling Speaker
Documents
Speaker 8 john o'connor
Education
Mesa Speaker Presentation 8 28 08 Pdf
Technology