IMPLEMENTATION OF HACCP TO BULK CONDENSED MILK PRODUCTION LINE

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IMPLEMENTATION OF HACCP TO BULK CONDENSED MILKPRODUCTION LINEAli A. Ali a & Randall M. Fischer ba Virginia State University , Petersburg, VA, 23806, U.S.A.b Maryland and Virginia Milk Producers Cooperative Association, Inc. , P.O. Box 184, Laurel,MD, 20725, U.S.A.Published online: 02 Nov 2011.

To cite this article: Ali A. Ali & Randall M. Fischer (2002) IMPLEMENTATION OF HACCP TO BULK CONDENSED MILK PRODUCTIONLINE, Food Reviews International, 18:2-3, 177-190, DOI: 10.1081/FRI-120014687

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IMPLEMENTATION OF HACCP TO BULKCONDENSED MILK PRODUCTION LINE

Ali A. Ali1,* and Randall M. Fischer2

1Virginia State University, Petersburg, VA 238062Maryland and Virginia Milk Producers Cooperative Association, Inc.,

P.O. Box 184, Laurel, MD 20725

ABSTRACT

A hazard analysis critical control point (HACCP) program itself is a straight-

forward and logical system of enhancing food safety through the prevention of

problems. This paper focuses on the role of each step in HACCP programs.

Condensed milk products, which have wide application in many sectors of the

food industry, are relatively short shelf-life products. Therefore, HACCP

analysis of this product is an important issue for public health. Implementation

of the HACCP system to production of bulk-condensed milk proved to be a

valuable tool for improving the safety and quality characteristics of that

product. Chemical and microbiological test results, in addition to the other

programs, play a lead role in developing monitoring strategies and generating

validation data to help the HACCP team assess the effectiveness of the

processing controls being used.

Key Words: HACCP; Hazard analysis; Critical control point; HACCP plan;

Dairy industry; Condensed milk

177

DOI: 10.1081/FRI-120014687 8755-9129 (Print); 1525-6103 (Online)Copyright q 2002 by Marcel Dekker, Inc. www.dekker.com

*Corresponding author. Fax: (301) 953-1979; E-mail: [email protected]

FOOD REVIEWS INTERNATIONAL

Vol. 18, Nos. 2 & 3, pp. 177–190, 2002

©2002 Marcel Dekker, Inc. All rights reserved. This material may not be used or reproduced in any form without the express written permission of Marcel Dekker, Inc.

MARCEL DEKKER, INC. • 270 MADISON AVENUE • NEW YORK, NY 10016

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INTRODUCTION

At the beginning of the 19th century, food scientists in Europe, England,

and the United States began working on the possibility of preserving milk as a

concentrated liquid. Evaporation technology applied to dairy products

developed remarkably since the American, Gail Borden, first developed the

process in 1856. Industrial production of condensed milk started around the

middle of the 19th century. Evaporated or condensed milk is produced by the

process of evaporation where water is progressively removed to effect the

concentration of milk solids, and of other solids so that the formulation of the

final product dictate their presence. Condensed milk is manufactured for use as

a food ingredient in its own right, finding application in many sectors of the

food industry. The product has a relatively short shelf-life of 2–3 days and

care must be taken to avoid the presence of Escherichia coli and Pseudomonas

spp., which indicate the occurrence of post-pasteurization contamination. The

production of condensed milk with acceptable organoleptic properties and that

is safe for consumption can be assured only when the microbiological quality

of the raw milk, pasteurization of the condensed products, and prevention of

post-heat treatment contamination during storage and distribution are

continuously controlled and tested.

Hazard Analysis Critical Control Points or HACCP, is an international food

safety system. In the United States, the Food and Drug Administration (FDA) and

the United States Department of Agriculture (USDA) have formulated regulations

that many food companies must follow. HACCP is a preventive, structured,

systematic, and documented approach to ensure food safety.[1,2] It identifies

biological, chemical, and physical hazards, and develops preventive measures

throughout food manufacturing to monitor a product’s compliance to a standard.

On the basis of common-sense application of technical and scientific principles to

the food production process, HACCP is an effective tool used to prevent

substandard finished goods from reaching the marketplace. The seven HACCP

principles are: (1) conduct a hazard analysis; (2) identify the critical control points

(CCP); (3) establish critical limits; (4) establish a monitoring system to ensure

control of the CCP; (5) establish corrective actions to be taken if critical limits are

exceeded; (6) document the HACCP plan; and (7) verify the HACCP system.

These principles have international acceptance and details of this approach have

been published by the Codex Alimentarius Commission[3] and the National

Advisory Committee on Microbiological Criteria for Foods.[4] Over the last

10 years, the HACCP concept has been rapidly developed and has found

applications in various products including chilled and refrigerated foods,[5,6]

seafood,[7] meat, and poultry.[8] Recently, several applications of HACCP in milk

and milk products have been reported,[9,10] but condensed milk products were not

among them. With these facts in mind, the present study was performed to

describe the HACCP analysis of the process used to produce bulk-condensed skim

milk and bulk-condensed whole milk. Furthermore, this study provides the basis

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for HACCP plans for bulk-condensed whole and skim milk, and guidance as to its

most effective practice.

CHEMICAL AND MICROBIOLOGICAL TESTING IN AN HACCPSYSTEM

A HACCP plan requires various tests as tools to control hazards. These tests

are designed to identify and control every possible physical, chemical, or

microbiological contamination. Milk samples may be analyzed for antibiotics

(amoxicillin, ampicillin, ceftiofur, cephapirin, and pencillin G), for example, by

using the rapid one step assay (Charm SL Beta Lactam, Charm Sciences, Inc.,

MA). Fat, protein, and somatic cells are measured by infrared analysis (Foss FT

120, Foss North America, Inc., USA). Aflatoxin M1 and pesticides[11] and

standard plate counts (SPC) are measured.[12] The skim (PC) and whole (WC)

condensed milk are analyzed for Total Solids, Fat, and SNF by infrared analysis,

SPC,[12] coliform counts,[13] phosphatase and adenosine triphosphate (ATP)

(Charm II 6600, Charm Sciences, Inc., MA), Listeria counts[14] and Salmonella

counts.[15]

CONDENSED MILK

Condensed or concentrated milk (21 CFR 131.115) is the liquid food

obtained by partial removal of water from milk. Bulk-condensed milk is usually

made by evaporation of manufacturing-grade milk without addition of sugar or

any other preservative material. The primary use of the product is as a source of

milk solids in confectionery, bakery, and other manufactured foods. Heat

treatments vary, but begin with pasteurization. Post-pasteurization temperatures

can reach 93.58C for 3 min depending on the desired outcome of viscosity,

bacteriological quality, and other physico-chemical properties. Skim milk

typically reaches the first effect at 70–728C and falls to 558C by the last effect.

CONDENSED MILK FLOW DIAGRAM

After milking, the raw milk is chilled to below 48C and kept at this

temperature during its transportation to the dairy plant. At the plant, the receiver

grades each milk load for odor, temperature, and foreign matter. The receiving

person must not unload a truck unless he/she is certain it has been tested negative

for antibiotics. After receipt, the milk is mechanically filtered and stored in silo

tanks. For the manufacture of bulk skim condensed milk (Fig. 1), the milk is

forewarmed (pre-heated) to 50–558C and skimmed (,0.5% fat) in a separator.

The skim milk is pasteurized at 768C for at least 15 sec and concentrated by

evaporation to the desired solids level. The condensed skim is then cooled to

BULK CONDENSED MILK PRODUCTION LINE 179



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,58C and stored in a silo, ready for dispatch. For the manufacture of bulk whole

condensed milk, the process is identical except the separation step is eliminated.

Both bulk skim condensed and bulk whole condensed milk are made without any

additives. The products have a relatively short shelf-life of 2–3 days.

ANALYSIS OF BULK-CONDENSED MILK CCPs

Raw Milk

The milk should be obtained from healthy animals under hygienic conditions.

Milk drawn aseptically from a healthy udder is not sterile, but contains low numbers

of microorganisms. These are predominantly micrococci and streptococci, although

coryneform bacteria including Corynebacterium bovis are also fairly common. The

bacterial count of fresh milk is significantly increased by mastitis, which in 95% of

the cases, the pathogens responsible were Staphylococcus aureus, Staphylococcus

epidermidis, and some Micrococcus strains.[16] These microorganisms are

Figure 1. Flow diagram of bulk-condensed skim milk and bulk-condensed whole milk production

with identification of Critical Control Point (CCP).

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pathogenic to man and some strains of mastitic Staph. aureus have been shown to

produce enterotoxin. Preventive measures include regular veterinary checks and the

cleaning of the udder before and after milking with appropriate antiseptics. Records

must be kept for each animal. All milk handling equipment should be designed to

“the 3-A sanitary standards” and be well maintained. Correct use of sanitizers and

strict control of temperatures is critical. Milk handlers should be made aware of their

responsibilities as food handlers and trained with respect to personal hygiene. An

increase in somatic cells indicates an unhealthy animal in need of antibiotic therapy.

Milk is then considered inappropriate for collection for at least 72 hr.[17] Post-

treatment animal feed must be controlled regarding its content in various metals and

other elements, chemical organic substances, and the presence of toxic plants.[18]

Raw Milk Receipt

High quality raw milk is the basis for production of high quality condensed

milk and other dairy products (Table 1). Milk is a good medium for the growth of

microorganisms and there is a high risk of quick microbiological deterioration of

quality, making production of quality finished goods impossible. Apart from the

expectation that incoming raw milk complies with the cooperative’s standards, the

company quality policy includes an economic incentive for quality. Failure to

meet basic standards can result in shipment refusal. The quality standards have

been issued under the company Quality Assurance Policy. The following quality

characteristics have been set for the raw milk: (1) the milk should be stored at the

farm in bulk tanks maintained in proper operating condition at all time; (2) the

temperature of milk at the time of pick up should not exceed 58C; (3) the milk shall

have good flavor, be free of off-odors, and be free of any visible contaminants or

foreign materials; and (4) the milk shall be free of growth inhibitor/antibiotics

before receiving. Raw milk quality is a CCP because the reception test is an

acceptance test. Long exposure of milk to elevated temperatures during

transportation encourages the growth of pathogens. Raw milk quality parameters

include SPC, somatic cell count (SCC), freezing point, and antibiotic status.

Table 1. Raw Milk Quality Standards

Quality Characteristics Limitsa Action Levela Test Results

Acidity (%) 0.16–0.17 .0.21 0.15 ^ 0.01

Standard plate count (mL) 10,000–20,000 .100,000 15,609 ^ 3,392

Somatic cell count (mL) 150,000–300,000 .750,000 357,744 ^ 39,689

Freezing point (8C) #20.535 .20.530 20.534 ^ 0.011

Inhibitors/antibiotics Negative Positive Negative

Pesticides residue ,FDA standard ,FDA standard Not detected

a Limits and action level according to the Code of Federal Regulations, company specification and

customer requirements.




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Filtration of Raw Milk

Raw milk is filtered in order to remove a considerable portion of the visible

sediment and any extraneous material that represents a physical hazard. The materials

used to filter the milk come from the manufacturer in a sterile condition, but may be

contaminated by exposure or careless handling. Filtration of raw milk is a control

point (CP) because it has only a small effect on the bacteriological quality of the milk.

At this stage, the microbiological, or the physical factors that affect milk quality can

be controlled by careful handling and periodic check-up of the filter’s effectiveness.

Storage of Raw Milk

Raw milk must be refrigerated at a temperature below 58C after production.

Because contaminating organisms go through a lag phase in freshly produced

milk, where growth and propagation are very low, multiplication of

microorganisms can be reduced significantly by immediate chilling. During

chilling, although the growth and propagation of mesophilic bacteria are reduced,

psychrotrophic bacteria can develop very rapidly. These bacterial groups can

break down lactose, protein, and fat in milk and some produce proteolytic and

lypolytic enzymes. Although these microorganisms are completely inactivated by

pasteurization, their enzymes are very heat resistant and continue to cause flavor

problems even after heat treatment.[19,20] Moreover, at temperatures below 68C,

Bacillus cereus grows and forms spores that are unaffected by pasteurization.

Bacillus cereus is of great importance because it is capable of producing a food

poisoning toxin.[21,22] To avoid the risk of potentially troublesome microorgan-

isms in raw milk, fresh milk should be kept at the lowest possible temperature

(48C) and used within 72 hr. Storage temperature is a CCP because elevated

temperatures contribute significantly to deterioration of raw milk quality.

Heat Exchange and Mechanical Separation

For production of condensed skim milk, the milk is generally pre-heated to

50–558C. Milk is usually separated at temperatures between 38 and 628C to

facilitate separation and minimize damage to fat globules.[23] When the temperature

of the milk drops below 358C, fat losses in the skim milk begin. Cold milk serum is

more viscous than warm serum and, therefore, offers greater resistance to the

migration of the fat particles. A second important factor is that the specific gravity of

milk fat increases with lowered temperatures and lowers the difference between the

weight of the fat and the milk serum. Cream separated at temperatures below 458C,

however, contains active milk-derived lipases[23] that can initiate the development

of rancidity during the short interval between separation and pasteurization.

Handling of separated cream at the plant is designed to minimize any damage during

cream handling since the cream is pasteurized directly after separation. The cream

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produced is not considered a CCP for condensed products as it is in cream

production. In the separation step, the CPs are that the correct temperature is used,

the equipment is fitted with a thermograph, routine inspection of thermograph

records is conducted, and the equipment is maintained on a preventative basis.

Pasteurization

Pasteurization is a public health measure, which, if properly applied,

adequately protects against all infectious milk-borne disease organisms that may

have entered the milk prior to pasteurization. As more and more high quality milk

has become available, questionable and often inferior supplies have been largely

eliminated. In high-temperature, short-time (HTST) pasteurization, the typical

temperature–time conditions are 728C for 15 sec followed by cooling to 328C.[24]

This heat treatment destroys all vegetative forms of bacteria, psychrotrophic

microorganisms, yeasts, and molds.[19] Heat treatment conditions (728C/15 sec for

low heat and 938C/3 min for high-heat condensed milk) used in the manufacture of

bulk-condensed milk depends on final use of the products.

It is important that the plant operator understand the HTST process in order

to maintain proper surveillance over the equipment. The following equipment and

processes are involved as milk passes through the HTST pasteurization system:

balance tank, pump, and the heat change sections of regenerative heating, holding,

and regenerative cooling (Fig. 2). Equipment and field tests should be performed

Figure 2. Typical HTST plate pasteurizer flow chart. (Courtesy of APV Crepaco Inc.)




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by plant QC and regulatory agencies according to the Grade A pasteurization milk

ordinance (PMO) appendix M (1995). The plate heat exchanger is commonly used

in HTST units (Fig. 3) for heating, cooling, and regeneration. It is compact,

simple, easily cleaned, and easily inspected. Routine checks of plates for leaks are

carried out every 3 months. The ability of HTST pasteurizers to assure a safe,

finished product hinges on the reliability of the time–temperature–pressure

relationships that must prevail whenever the system is in operation (PMO, 1995).

Indicating and recording thermometer accuracy must be verified at least once

every three months or whenever the recording pen-arm setting requires

adjustment. Flow diversion under-pasteurization temperature and indicating

thermometers must be verified daily. Holding time takes into account diversion

valve response time.

Pasteurization focuses on minimizing the probability that pathogenic

microorganisms might survive the process so that the public health risk is

negligible. The procedures of pasteurization, however, can neither destroy nor

eliminate the presence of toxins, bacterial agglomerations, and residues of chemical

and physical substance such as antibiotics and metals.[25] Therefore, the existence

of at least one CCP before pasteurization is essential (e.g., reception of raw milk).

Plant operators must be well trained to control the thermal destruction of vegetative

pathogens. Equipment conditions must be monitored on a regular and routine basis

including the temperature of milk in holding tubes and after cooling. Examination

of correct flow diversion at restart of each run by a trained specialist, is critical.

Because of the importance of this step, pasteurization is a CCP. The quality control

department frequently checks the essential sources of contamination such as air,

water, equipment, utensils, and people,[26] which are regarded as suspect and prone

to contamination. Frequent checks of thermograph records are required. Since the

thermal resistance of phosphatase is greater than that of nonspore-forming

pathogenic microorganisms, heat-treatment of at least 728C for 15 sec, applied

commercially to inactivate phosphatase, will kill all nonspore-forming pathogenic

Figure 3. Plate heat exchangers—flow patterns.

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microorganisms.[27] Thus, examination of phosphatase test to determine whether

pasteurization was done properly is also required.

Evaporation

Concentration after heat treatment takes place under vacuum in multiple-

effect evaporators. The degree of concentration depends on the product end use.

The product leaving the evaporator is not sterile and further opportunities for

contamination occur during post-evaporation handling. A high standard of

hygiene together with rapid and efficient cooling is seen as an integral part of

processing. It is important that the evaporator works under optimal hygienic

conditions. After evaporation, the product is normally cooled to 20–258C. The

CPs at the evaporation step are the examination of plant records for chemical,

physical, bacteriological, and temperature standards according to the PMO,

supplement 1.[28] Also, it is necessary to examine the temperature (cooled to 58C

or less), bacterial limits (not to exceed 30,000 per g), coliform (not to exceed 10

per g), phosphatase (no positive results), and drug residue (no positive results).

Storage

Condensed milk is not considered a high-risk product provided the milk

receives a heat treatment equivalent to pasteurization. However, with a water

activity (aw) level between 0.98–0.60, it will support the growth of all common

milk spoilage organisms. Post-process contamination is a risk, so programs must

be in place to prevent contamination after pasteurization. Storing the condensed

milk at the wrong temperature affects safety and shelf-life. This step is a CP. The

condensed milk shall be stored at 5–78C in a washed and sanitized tank for no

longer than 72 hr. Finished product tanks should be swabbed periodically for ATP.

The ATP associated with food and biological materials provides a highly sensitive

indicator of hygiene effectiveness, which is recognized as an important part of the

quality and HACCP programs implemented at the plant.

Distribution

Two important questions related to dispatching of the bulk-condensed milk

must be considered by the plant HACCP team. Could the product be abused by the

customer causing it to be unsafe? Can the product be traced through the

distribution chain in a timely manner, and withdrawn from the market place in the

event of a food safety issue? The correct answer to these questions is very

important. Condensed milk is routinely analyzed chemically and microbiologi-

cally for SPC and coliform bacteria (Table 2). Each tank provided and each loaded

truck is subjected to this analysis. Additionally, Staphylococci, Salmonella, and




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Listeria counts are carried out every 3 months or when needed. A documented

product trace/recall program should be in place and mock recalls conducted

semiannually. Moreover, a uniform tanker seal program should be in place. The

receiving operator should seal the manhole, CIP ports, and pump compartment

after the trailer is sanitized. The driver must document seal numbers and ensure

that the trailer remains sealed at all times, except to unload and load the milk

product. This step is a CP. The condensed milk shall be shipped at 5–78C in a

washed and sanitized trailer.

HACCP DESCRIPTION PLAN FOR BULK-CONDENSED MILK

Before putting the HACCP principles into place in the plant, the HACCP team

must establish the required prerequisite program and its preliminary setup. This

program includes premise control, receiving and storage control, equipment perform-

ance and maintenance control, personnel training, sanitation, and recall procedures.

All these prerequisite areas are covered under the company quality management

system (QMS, ISO 9000/2000). The bulk-condensed milk HACCP program (Table 3)

is a formal document that pulls together the key information from the HACCP study,

and contains details of all that is critical to food safety management.

An important role of HACCP is to help the food processor build safety into

processes through identification of key or critical control measures that prevent,

eliminate, or reduce hazards to acceptable levels. A HACCP program shifts the

focus of controls toward monitoring in-process preventive control measures. This

shift is important because of the increased awareness of the shortcomings of

microbial testing of finished products. As FDA reported in the Federal Register (1)

“End-product testing does not address the root causes of food safety problems; it is

not preventive by design and requires that a large number of samples be analyzed

to ensure product integrity.”

Table 2. Control Measures and Chemical and Microbiological Analysis of Condensed Milk

Control Limitsa Action Levela Test Results

Acidity (%) 0.56 ,0.50 to .0.64 0.58 ^ 0.30

Antibiotic Negative Positive Negative

Phosphatase Negative Positive Negative

Aflatoxin (ppb) 0.50 Maximum Not detected

Pesticides residue ,FDA standard .FDA standard Not detected

SPC (g) ,10,000 .20,000 3,000 ^ 600

Coliforms (coli/g) Negative .10 ,1

Staphylococci (coagulase þ /g) Negative .10 Negative

Salmonella Negative Positive Negative

Listeria Negative Positive Negative

a Limits and action level according to the Code of Federal Regulations, company specification and

customer requirements.

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HACCP SYSTEM VERIFICATION

Microbiological and chemical results are normally tabulated (Tables 1 and 2)

and analyzed against the guideline specification and the company standards to

identify quality trends. If results indicate any product out of specification, the

source of the problem must be investigated and corrective actions should be taken.

Documented procedures, testing of CIP systems, and analysis for product safety

are usually audited by self-inspection and by regulatory inspection. The audit

results are also analyzed to determine the effectiveness of the HACCP system.

CONCLUSIONS

This study focuses on aspects of HACCP in the dairy industry, with a special

focus on the bulk-condensed milk products. Implementation of the HACCP

system to the production of bulk-condensed milk proves to be a valuable tool for

improving the safety and quality of the product. Chemical and microbiological

results can be used as monitoring tools for establishing the critical limits and to

take corrective action as required. They can also be used to validate and verify the

HACCP plan.[29] All (i. e., raw milk producers, operators, manufacturer, retailer,

and consumer) parties involved must adhere to the prerequisite areas for HACCP

and the HACCP system itself. In this way, the overall performance of the

condensed milk production plant after implementation of the HACCP plan is

improved, with further improvements anticipated within the frame of a total

quality system incorporating ISO 9000/2000, ISO 14001 and HACCP.

ABBREVIATIONS

ATP adenosine triphosphate

CCP critical control point

CFR code of federal regulation

CP control point

FDA Food and Drug Administration

HACCP hazard analysis critical control point

HTST high temperature short time

IDF International Dairy Federation

ISO International Organization for Standardization

ISO 9000 (QMS) quality management system

ISO 14000 (EMS) environmental management system

PC plan condensed milk

SPC standard plate count

WC whole condensed milk

USDA United State Department of Agriculture

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Documents

IMPLEMENTATION OF HACCP TO BULK CONDENSED MILK PRODUCTION LINE