ALS Focus on Food · Web viewTo use a moistened swab, remove a stick swab from the sterile wrapping and moisten the tip by immersing it in a tube containing the diluent/neutralizer

Business Name: Environmental Monitoring PlanWRITTEN BY

DATE

Australian Laboratory Services Pty LtdUnit 10, 2-8 South Street, Rydalmere, NSW,

Australia 2116T +61 2 8832 7535 M +61 476 830 459

E [email protected]: 84 009 936 029

Contents1. Introduction............................................................................................................................................22. Objectives..............................................................................................................................................2

2.1 Scope and limitations...................................................................................................................23. Risk analysis and assessment................................................................................................................2

3.1 Criticality factors..........................................................................................................................33.2 Sampling points............................................................................................................................33.3 Room identifiers...........................................................................................................................33.4 Risk assessment of each room.....................................................................................................4

4. The Environmental Monitoring program.................................................................................................54.1 Organisms to be tested for...........................................................................................................64.2 Sampling points............................................................................................................................6

4.2.1 Criticality Factor 1-2......................................................................................................74.2.2 Criticality Factor 3-4......................................................................................................74.2.3 Criticality Factor 5-6......................................................................................................7

4.3 Establish baseline.........................................................................................................................74.4 Design of a rotational sampling plan............................................................................................74.5 Trending results...........................................................................................................................84.6 Record corrective actions.............................................................................................................84.7 Sampling technique.....................................................................................................................8

4.7.1 Air sampling – settle plates...........................................................................................84.7.2 Surface swabbing – hygiene monitoring........................................................................9

5. Alert, action limits and corrective actions..............................................................................................96. Appendix 1 – Facility floor plan............................................................................................................117. Appendix 2 – Compressed air sampling points.....................................................................................128. Appendix 3 – Root Cause Analysis (RCA).............................................................................................13

8.1 Fishbone diagram.......................................................................................................................138.2 5 Steps in Root Cause Analysis..................................................................................................13

9. Appendix 4 – Settle plates and swabs used for Environmental Monitoring..........................................149.1 Settle plates...............................................................................................................................149.2 Hygiene swabs...........................................................................................................................14

10. Appendix 5 – Training statement.........................................................................................................1511. References...........................................................................................................................................17

Right Solutions • Right Partner www.alsglobal.com

mailto:[email protected]

Business Name: Environmental Monitoring Plan

1. IntroductionEnvironmental Monitoring describes the microbiological testing undertaken in order to detect

changing trends of microbial counts and microflora growth within cleanroom or controlled environments. The results obtained provide information about the physical construction of

the room, the performance of the Heating, Ventilation, and Air-Conditioning (HVAC) system, personnel cleanliness, gowning practices, the equipment, and cleaning operations. (Sandle)

This plan has been prepared by Name, Role at Business Name and address.

The facility manufactures Product type product with the following ingredients:

Ingredients list

2. ObjectivesIn developing an adequate environmental monitoring programme, there should be a balance between using resources efficiently and monitoring at sufficiently frequent intervals so that a meaningful picture can be obtained.The key objectives of this plan are to identify sampling points for air quality monitoring and process hygiene swabbing together with frequency of sampling and tests to be conducted.Taking a risk-based approach and utilising microbiological sampling strategies documented in International Commission for the Microbiological Specifications of Foods publications (ICMSF), an environmental monitoring program is designed to verify that food hygiene controls implemented as part of a documented food safety management system (FSMS) are effective.

2.1 Scope and limitationsMicrobiological testing can be a useful tool to support a documented FSMS, but cannot be relied upon of itself to ensure that safe food is produced.

This plan is limited to setting out a risk-based approach to monitoring the air quality of the production facility and the hygienic state of production equipment.

3. Risk analysis and assessmentAs part of the formal risk assessment of the facility, processes and production environment, a site walk through was undertaken on DATE, by the following personnel:

EM team members

This risk assessment is based upon information and observations from that visit, combined with additional information from the site HACCP plan, document number xxxxx.

3.1 Criticality factors When establishing an environmental control program, the frequency of monitoring different

controlled areas can be determined based on 'criticality factors' relevant to each specific area. (Sandle)

The following table establishes the criticality factors upon which the risk assessment will base the monitoring frequency for each room, process or area of the facility. The criticality factor is defined with examples where appropriate and a risk likelihood descriptor applied.

Business Name EM plan P2 of 18



Criticality Factor Definition

Likelihood of environmental impact on end

productMonitoring Frequency

1 Aseptic filling where no further processing takes place – contamination here would have severe

impact on end product, as contamination could not be reduced or removed by a further processing step

Highly likely Daily or each batch

2 Final formulation stage – applies where the final stage may be a sterile grade filter

Likely Weekly

3 Area of ambient temperature and high water presence, where the product is open to the

production environment and contamination may be introduced

Moderately likely Fortnightly

4 Temperature controlled areas with little or no exposure of the product to the environment

Unlikely Monthly

5 Indirect exposure to the environment is highly unlikely to introduce contamination that will impact

the end product. If contamination is introduced, controls further in the processing will remove or reduce the contamination to acceptable levels

Very unlikely Quarterly

6 An area that is uncontrolled or where there is unlikely to be any significant microbial contamination (for examples, freezers)

Highly unlikely Every 6 months

3.2 Sampling pointsSampling points will be determined via a risk assessment of the rooms and processes within each room. The highest risk activities or process points within the room will be established as the sampling points both for air settle plate samples and hygiene swabs.

Results from each sampling point will be trended and reviewed regularly in order to determine whether sampling frequencies are acceptable or need to be assigned a different criticality factor.

Please refer to the facility plan in Appendix A for a visual representation of the sampling points within each room or area.

3.3 Room identifiersEach room in the facility has been assigned an ID code, based on the number of the room on the site plan and the room’s anticipated role once the facility is operational.

The following table lists those identifiers:

Room Id (Name) Room Id (Code) 1234567




8910111213141516171819

For the purposes of this plan, risk scores will be applied to each room based on the anticipated function outlined in the table above.

Any changes to the function once the facility is operational will require a review of the risk scores and possible reclassification of the room.

Initial monitoring results will also be utilised to further refine the risk scores and category of each room.

3.4 Risk assessment of each roomThe following risk assessment table is based on current knowledge of the facility and anticipated use of each room and area. It should be noted that at the time of writing this plan the facility is still in the process of construction and the activity for each room is subject to change.

Initial sampling results of the facility in the “as-built” state (ISO) will be utilised to enhance and either confirm or review current risk ratings for each room.

Below is an example only, please edit with your own information

Room ID Activity Risk to final product

Reason for assessment Criticality factor

001FCR1 Cooking room Medium Kill step/heat treatment 3

002FFR1 Filling room High Exposed product, no further processing 1

003FDB1 Dispensing/blending

High Exposed product, no further processing 2

004FTS1 Tray storage Medium Damp room, no temperature control, trays will hold product therefore cleaning and

sanitisation requires monitoring

3

005FWB1 Wash bay High Wet room, no temperature control, high water pressure could spread contamination

2

006FBP1 Bulk packing Medium End product not exposed, cross contamination possible

4

007FAL1 Airlock Medium End product not exposed, cross contamination possible

4

008FST1 Staging Medium End product not exposed, cross contamination 4Business Name EM plan P4 of 18



possible

009FAL2 Airlock Medium End product not exposed, cross contamination possible

4

010FPP1 Primary packing Medium End product not exposed, cross contamination possible

4

011FSP1 Secondary packing Medium End product not exposed, cross contamination possible

4

012MPP1 Milk powder primary packing

Medium End product not exposed, cross contamination possible

4

013MSP1 Milk powder secondary packing

Medium End product not exposed, cross contamination possible

4

014FCR1 Change room Low Extensive hygiene controls in place, GMP, PPE 5

015FPC1 Production corridor Medium End product not exposed, cross contamination possible

4

016FPC2 Packaging corridor Medium End product not exposed, cross contamination possible

4

017FMA1 Maintenance area Low Contact with end product unlikely, hygiene controls in place to separate staff and product

6

018FMR1 Meeting room Low Monitoring required initially, but cross contamination unlikely due to existing

hygiene controls

6

019FMR2 Meeting room Low Monitoring required initially, but cross contamination unlikely due to existing

hygiene controls

6

4. The Environmental Monitoring programThe microbiological safety of commercially produced food products is enhanced by the effective design and implementation of Good Hygienic Practices (GHP), incorporating a comprehensive risk analysis.

This is achieved by taking a systematic approach to prevention and mitigation of the entry of microbial contaminants, as outlined below:

Prevention of entry of microbes into areas close to the main production facility (High Hygiene Zone)

In the event of entry, prevention of establishment in the premises

In the event of establishment, prevention or limitation of microbial multiplication, which would favour persistence and dissemination throughout the premises

In the event of presence, implementation of corrective actions to ensure control of microbial concerns at low levels or eradication where feasible.

An effective Environmental Monitoring plan will incorporate the following principles and elements:

1. Identifying the organisms to be tested for: these could be specific pathogens of concern to the product or indicator organisms




2. Strategic identification of sampling points based on the ICMSF Zone Concept (the highest risk Zone 1 including food contact surfaces, such as fillers, bottles, storage tanks, preparation tables etc and areas where product is exposed to the air)

3. Establishing a baseline that demonstrates the production environment is under hygienic control – this will enable the comparison of results over time to quickly spot any variations

4. Designing a sampling plan that allows all areas of concern to be sampled over a period of time

5. Regular review and comparison of test results to identify long term trends and potential weaknesses in the sanitisation program

6. Recording any corrective actions or investigations that may be undertaken when results indicate that the risk of contamination has increased

7. Ensuring that sampling is undertaken with careful regard to aseptic techniques and that only trained and responsible persons are permitted to engage in sampling

4.1 Organisms to be tested forBased on the known product specifications, air quality and swab samples will be analysed for the following organisms:

Standard plate count

Yeast and mould

Standard plate count gives an indication of the total aerobic microbial loading in a facility or on a surface and tracking results over time is a valuable guide to whether the facility is under hygienic control.

The presence of yeast and mould spores in High Hygiene areas can be a significant spoilage factor for the finished product – trending results over time will provide valuable information on the ability of the organism to penetrate the main processing and storage areas.

4.2 Sampling pointsThe rooms identified in section 3.4 Risk assessment of each room above will be sampled with the frequency determined by the risk assessment and according to the risk rating applied.

The convention for naming sampling points on sample submission forms is as follows:

Room ID followed by sample point identifier. Therefore, for Room 1 (Room name), the sample points will be identified as follows:

001FCR1A – air settle plate (SPC, Y&M)

001FCR1B – air settle plate (SPC, Y&M)

001FCR1C – swab site (SPC, Y&M) – this point will generally be machinery that contacts product

001FCR1D – swab site (SPC, Y&M) – this point will be doors/door handles at entrance to room

For rooms where there are only 1 air settle plate and one swab sample recommended, we have used the convention of A and D suffixes to denote air sample and door swab respectively.

Appendix 1 – Facility floor plan ADD IN YOUR FLOOR PLAN.

Sampling points within each room have been determined based on the assumed position of machinery, personnel flow and HVAC equipment/intake and is subject to confirmation once the facility is operational. However, the following guidelines should be considered according to Criticality Factor.




4.2.1 Criticality Factor 1-2

For each room carrying a Criticality Factor of 1or 2, we recommend a minimum of 2 sampling points for settle plates – one positioned at the point of greatest risk of contamination (ie close to exposed product) and the other at or near the point of entry.

For swabs, we recommend a minimum of 2 sampling points – directly on the machinery performing the critical activity (ie filling) and on the doors or point of entry to the room.


For large areas, such as production corridor, a number of settle plates can be placed along the corridor near to points of access to other rooms. For large rooms, 2 sampling points for air plates.

For swabs, initial sampling can concentrate on entrances, production machinery and/or any equipment that may be removed from the room or shared with higher risk areas.


Initial sampling should focus on points where there is a potential for contamination to be spread to other areas. For settle plates, this will be near to entrances/exits and any HVAC equipment.

Swab sampling should focus on door handles.

4.3 Establish baselineIt is recommended that, initially, all points will be sampled to establish a baseline for future comparison.

Sampling should only commence once all construction work has been completed and before production starts.

4.4 Design of a rotational sampling planThe following sampling plan is recommended to be implemented as soon as practicable:

1. Initial sampling of all air quality and swab sampling points, irrespective of risk levels – this will establish the baseline for all sampling points

2. Review initial results and confirm or amend ongoing Criticality Factors and risk

3. Trend results and review periodically once production has started (on a weekly basis initially, then monthly depending on results)

4. Use the following assessment formula to determine ongoing risk once the facility is under full scale production: contamination rate (%) = settle plate count x area of product/area of petri dish x time product exposed/time settle plates exposed x 100

4.5 Trending resultsResults are trended to easily spot variations in air quality and equipment hygiene over time. There may be some natural variation in air quality, depending on the season and prevailing weather, amongst other considerations.

For example, the increased winds and presence of dust during certain months could lead to a deterioration in air quality and these months may require increased cleaning/sanitisation frequency or additional controls to maintain the desired quality.

Trending results enables us to determine whether the facility is not under hygienic control or whether test results are indicative of seasonal or other variations.




4.6 Record corrective actionsWhen results indicate that the air quality is not under hygienic control, any corrective actions taken will need to be recorded in the day book/diary or Food Safety Plan – for example, if there is an increase in mould counts in the Wash room, additional precautions may need to be introduced.

Some useful tools for undertaking root cause analysis are the “5 Whys” technique and the Ishikawa (or “Fishbone”) analysis diagram1.

4.7 Sampling techniqueSampling for microbiological analysis needs to be undertaken by trained individuals with proper regard for aseptic techniques, as below:

4.7.1 Air sampling – settle plates

Settle plates are used to directly sample the likely number of microbes depositing onto a product or work surface over a set time period.

The following is a best practice technique for the exposure of settle plates in the production environment.

1. Examine the plates for contamination prior to use

2. Assemble the plates required and ensure that the correct information is written on the base of the plate with a permanent marker. Do not mark the lid of the plate, as there is always a possibility of lids coming off and being replaced on the incorrect sample plate

3. The following details may be marked on each plate:

i. date and time sample taken

ii. area/location of sample

iii. unique identifier/sample number (see 3.2.1 above)

4. Transfer the plates into the area where they are to be exposed as identified in your environmental sampling plan

5. Place the plates in the sampling positions with the lids still on

6. Remove the lids to expose the surface of the medium, resting the lid face down on the surface next to the plate. Take care not to put fingers on plates and avoid passing anything over the top of plates being exposed

7. Leave plates exposed for between 15 minutes and 1 hour, making sure to record the exposure time

8. After exposure:

i. Replace lids of plates carefully, without touching the surface of the agar

ii. Remove from production area

iii. Place plates in a zip lock bag and label with the details of the area and date/time as before

iv. Collect all plates exposed and secure in a suitable container for transportation to the lab

1 See Appendix 2: Root Cause Analysis toolsBusiness Name EM plan P8 of 18



9. Ensure that one plate is marked as “Control” and the lid kept on – ie not exposed

10. Complete and enclose the sample submission form – also email a copy to

4.7.2 Surface swabbing – hygiene monitoring

1. Crack the seal on the swab, and dip the head in the relevant neutralizing solution (some swabs already contain a neutralizing solution)

2. Swab a 10x10cm area with a cross hatch technique (see below) – for flat surfaces

3. For uneven surfaces, swab as wide a surface area as possible, ensuring that the swab makes contact with cracked or scarred surfaces, rollers, hard to reach machine parts etc

4. Return swab to its transport casing; make sure the lid is on tightly

5. Label the swab clearly with indelible pen

5. Alert, action limits and corrective actionsThe following table summarises the initial baseline alert, action limits and applicable corrective actions. These limits are to be reviewed following the initial testing and results and once the facility is under full production.

Corrective actions will depend on the level of risk associated with the relevant room, activity and machinery involved. All corrective actions should be recorded in the diary or food safety plan corrective action record, so that they can easily be reviewed for effectiveness.

Settle Plates (SPC & Y/M) – Limit Criteria

Criticality Factor/ Risk category

Alert Limit &Corrective Action

Action Limit & Corrective Action

1-2, High Risk10cfu/plate or swab 50cfu/plate or swab

GMP clean room.

Re-test. Monitor. Record actions.

Investigate. Implement

Corrective Action/s. Monitor. Record actions

3-4, Medium Risk

50cfu/plate or swab 100cfu/plate or swab

GMP clean room.




5-6, Low Risk

100cfu/plate or swab 200cfu/plate or swab

GMP clean room.







Appropriate corrective actions in the event of the Action limit for a particular area being reached could include the following:

Increased end product testing surveillance from batches produced during the sampling period

Review of SSOPs and hygiene protocols – staff training/re-training may be necessary

Increase testing surveillance and add sampling points for affected room and associated activities

If only one room or sampling point is affected:

o check positioning of settle plates – is there anything nearby that may have caused the results? For example, HVAC intake – if so, check filters

o check swabbing point – if a door handle, who had access to the room during the monitoring period? If production team only, re-training may be necessary. If maintenance, review protocols for undertaking maintenance work to minimise risk of contamination

If more than one room or sampling point is affected, what is the common connection? Check air filters, traffic flow (wheeled and pedestrian), hygiene procedures, overhead rails, drains etc




6. Appendix 1 – Facility floor plan Enter Floor plan image here with sampling points




7. Appendix 3 – Root Cause Analysis (RCA)Root Cause Analysis (RCA) is a tool for answering the question of why an identified problem occurred in the first place. It seeks to identify the origin of a problem using a specific set of steps, with associated tools, to find the primary cause of the problem, so that one can:

Determine what happened

Determine why it happened

Determine what actions to take to reduce the likelihood that it will happen again

RCA assumes that systems and events are interrelated. An action in one area triggers an action in another, and another, and so on. By tracing back these actions, it is possible to discover where the problem started and how it grew into the symptom manifesting.

7.1 Fishbone diagram A fishbone diagram is often used to assemble the information required for conducting the RCA, as below:

7.2 5 Steps in Root Cause AnalysisThere are 5 steps in a typical RCA:

1. Define the problem – what exactly is happening?

2. Collect data

a. How long has the problem existed?

b. What proof is there that the problem exists?

c. What is the impact of the problem?

d. Analyse the problem in fullBusiness Name EM plan P12 of 18



3. Identify all of the possible causal factors, using one or more of these tools:

a. 5 Whys – keep asking “why” until the root of the problem is revealed

b. Drill down – break the problem into smaller parts with greater detail

c. Cause and effect diagrams – e.g. the Fish bone diagram above

4. Identify the Root Cause, including:

a. Why does the causal factor exist?

b. Why did the issue really occur

5. Recommend and implement solutions

8. Appendix 4 – Settle plates and swabs used for Environmental Monitoring

8.1 Settle platesThe settle plates used for air quality monitoring by ALS are 9cm diameter agar plates, with the following specifications:

Total aerobic plate count method – Tryptone Soya Agar (TSA): a general purpose, non-selective media for the rapid growth of bacteria cells. TSA contains enzymatic digests of casein and soybean meal, which provide amino acids and other nitrogenous substances, making it a nutritious medium for a variety of organisms. Glucose is the energy source. Sodium chloride maintains the osmotic equilibrium, while dipotassium phosphate acts as buffer to maintain pH.

Yeast and mould enumeration method – Sabouraud Dextrose Agar + Anti (Chloramphenicol) (SAB+Anti): Sabouraud Dextrose Agar is used for cultivating pathogenic and commensal fungi and yeasts. The high dextrose concentration and acidic pH of the formula permits selectivity of fungi. Sabouraud Dextrose Agar is used in the mycological evaluation of food. Sabouraud Dextrose Agar with Chloramphenicol is a modification of Sabouraud Dextrose Agar, with the addition of Chloramphenicol to increase selectivity against commensal microorganisms.

8.2 Hygiene swabsISO18593:2018(E) – Microbiology of the food chain — Horizontal methods for surface sampling states:

7.5.3.2 Moistened stick swab

To use a moistened swab, remove a stick swab from the sterile wrapping and moisten the tip by immersing it in a tube containing the diluent/neutralizer. Press the tip of the swab against

the wall of the tube to remove excess diluent/neutralizer. Place the tip of the swab on the surface to be examined and streak an estimated area of, e.g. ≤ 100 cm2, while rotating the

stick swab between thumb and forefinger. For flat surfaces, the sampling should be performed horizontally and vertically, e.g. 10 times in each direction. For hard-to-reach small surfaces, make sure to sample the entire described location including crevices, gaps, surface connections, etc. Return the stick swab in the tube with the diluent/ neutralizer. Make sure

the tube is closed so that the swab stays moist until the analysis.

ALS Food uses pre-moistened stick swabs in a diluent solution for environmental swabbing of a dry production environment.




9. Appendix 5 – Training material




Trainee signatures:

Trainer signature:




10. ReferencesICMSF. Microorganisms in Foods: Microbiological Testing in Food Safety Management. 7. Vol. 1. New York: Springer, 2002. Book.ISO. “ISO 14698-1:2003 Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods.” ISO. 2003.Sandle, Tim. “Environmental monitoring risk assessment.” Journal of GXP Compliance (2006): 54-73. Online Document.



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ALS Focus on Food · Web viewTo use a moistened swab, remove a stick swab from the sterile wrapping and moisten the tip by immersing it in a tube containing the diluent/neutralizer