CHAPTER

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Quality Assurance and

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Dairy Processing
John E. Stauffer

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1.1 Introduction, 3
1.1.1 Definition of Quality, 3
1.1.2 Quality Assurance Versus Quality Control, 3
1.1.3 Organization and Management, 4
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1.2 Hazard Analysis and Critical Control Points, 4
1.2.1 Basic Concepts, 4
1.2.2 Food Hazards, 5
1.2.2.1 Microbiological Hazards, 5
1.2.2.2 Chemical Contamination, 7
1.2.2.3 Extraneous Matter, 8
1.2.2.4 Functional Hazards, 8
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1.2.3 Critical Control Points, 8

1.2.3.1 Blended Products, 9
1.2.3.2 Raw Milk Quality, 9
1.2.4 Pasteurization, 12
1.2.4.1 Pasteurized Milk Ordinance, 12
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1.2.4.2 Pasteurization Conditions, 14

1.2.4.3 Two Tragedies in 1985, 19
1.2.5 Cheese Processes, 20
1.2.6 Ice Cream Processes, 23
1.2.7 Yogurt Processes, 25
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1.2.8 Butter and Milk Processes, 27

1.3 Product Specifications, 30
1.3.1 Food Additives and GRAS Substances, 30
1.3.2 Unavoidable Contaminants, 33
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1.3.3 Standards of Identity, 33

1.3.4 USDA Grades, 35
1.3.5 Analytical Methods, 37
1.3.6 Codex Alimentarius, 39
1.4 Good Manufacturing Practice, 40
1.4.1 Regulatory Requirements, 41

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 1.4.2 Sanitation, 41
1.4.2.1 Materials of Construction, 41
1.4.2.2 Equipment Design and Standards, 42
1.4.2.3 Cleaning of Equipment, 43
1.4.2.4 Sanitizing Compounds, 44

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1.4.2.5 Application of Cleaning/Sanitizing Solutions, 45

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1.4.2.6 Maintenance of Equipment, 46
1.4.3 Plants and Grounds, 47
1.4.3.1 Environmental Concerns, 47
1.4.3.2 Pest Control, 48

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1.4.4 Employee Training, 49
1.5 Product Labeling, 50
1.5.1 Ingredient Labeling, 50
1.5.2 Nutritional Labeling, 52
1.5.3 Fortification, 55
1.5.4 Imitation and Substitute Foods, 57
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1.5.5 Open Date Labeling, 59
1.5.6 Kosher Certification, 59
1.6 Packaging, 60
1.6.1 Functional Needs, 61
1.6.2 Materials Testing, 62
1.6.3 Tamper-Evident Closures, 63
1.6.4 Aseptic Packaging, 63
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1.6.5 Packaged Weight Control, 64

1.7 Distribution, 65
1.7.1 Shelf Life, 65
1.7.2 Warehousing and Shipping, 65
1.7.3 Product Recall, 66
1.8 Summary, 67
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1.8.1 Importance of Process Controls, 67

1.8.2 Need to Avoid Recontamination, 68
1.9 Future Developments, 68
1.9.1 The Promise of Biotechnology, 68
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1.9.2 Internationalization of the Dairy Industry, 69

1.9.3 Proliferation of New Products, 69
1.10 References, 70
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 L l Introduction

1.1.1 Definition of Quality

Traditional concepts of quality need to be modified when discussing dairy products.

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Quality can be thought of as the ''degree or grade of excellence," but something

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more specific should be added to this definition when coping with everyday prob-
lems. A survey by the Dairy & Food Industries Supply Association indicated that
the primary quality concern of dairy processors is the organoleptic attributes (taste
and texture) of their products. Safety issues, that is, bacterial control and sanitation,
ranked second among the concerns expressed.1 This priority undoubtedly reflected

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the outstanding progress that has been made over the years to ensure product safety.
Consumers also expect and demand convenience, sound value, and, increasingly,
good nutrition. The meaning of nutrition, however, has undergone dramatic changes.
Whereas at one time quality was equated with the fat content of a dairy product (the
richer the better), now consumers are substituting low-fat or "light" dairy products
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into their diets. This switch has been prompted by fears of excessive intake of sat-
urated fat, cholesterol, salt, and sugar, all of which have been shown to contribute
to such chronic diseases as hypertension, heart disease, and some cancers.2
The new concerns about nutrition have exerted a strong effect on consumer pref-
erences. Skim milk and cheese, for example, have become dominant staples as meal
items. At the same time such high-calorie treats as ice cream and sherbet remain
popular.3 In an attempt to have it both ways—good nutrition while being self in-
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dulgent—consumers are availing themselves of new introductions of engineered

dairy products containing fat substitutes and artificial sweeteners.

1.1.2 Quality Assurance Versus Quality Control

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A distinction should be made between quality assurance and quality control. Too
often these terms have been used interchangeably with the result that the difference
between them has become blurred. Quality assurance can be defined as a strategic
management function that establishes policies related to quality, adopts programs to
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meet the established goals, and provides confidence that these measures are being
effectively applied. Quality control is a tactical function that carries out those pro-
grams identified by quality assurance to be necessary for the attainment of the quality
goals.
Quality assurance covers a wide range of programs. It has oversight responsibility
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in the areas of product planning, manufacturing, customer service, and distribution.

Its duties include the approval of specifications for raw materials, additives, proc-
essing aids, finished products, labeling, and packaging. In the preview for a sym-
posium on dairy products, sponsored by the Institute of Food Technologists in June
1989, the point was made that, "Quality Management now involves all facets of the
process of moving milk from the producing farm to the processing plant to the
consumer."4

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 1.1.3 Organization and Management
In order to fulfill their responsibilities, dairy processors need to allocate significant
resources in terms of both manpower and funds to quality assurance. Perhaps no
other segment of the food industry can match these efforts. Indeed, the dairy industry

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is considered to be the most regulated. To carry out its mandate to produce safe,

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wholesome products, each processor requires the services of well trained and ex-
perienced personnel. These individuals must be melded into a strong organization
that is professional and dedicated to its tasks.
Management structure can best be illustrated by an organizational chart. Although
each company will favor its own management style, certain practices are widely

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accepted throughout the industry. Foremost among these practices is the need to
have the individual responsible for directing the quality assurance function report
directly to senior management.5 By this means senior management will have ready
access to operational data, and line supervisors will have an open line of commu-
nication. Nothing can be more important to quality assurance than defining individual
responsibilities and establishing clear channels of communication.
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1.2 Hazard Analysis and Critical Control Points
1.2.1 Basic Concepts
Process controls are necessary to produce a dairy product that is safe and acceptable
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to the consumer. The means by which such controls can be established is a meth-
odology known as Hazard Analysis and Critical Control Points (HACCP). The ef-
fectiveness of this procedure is so widely documented that it has received general
acceptance throughout the food industry. Therefore, HACCP is the basis for most
discussions of quality assurance including this treatment of the subject.
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Several steps are required during a HACCP review of a process. First, all the
potential hazards associated with the process are analyzed. These hazards will in-
clude microbiological dangers, possible chemical contamination, and the potential
inclusion of extraneous matter. Next, process parameters or control points that have
a direct bearing on the hazards in question are identified. Through practical experi-
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ence, it has been found that lack of control at any one of these points, for example,
ingredient inspection, pasteurization, or finished product analysis, may cause, allow,
or contribute to a hazard in the final product. Thus, these control points are deemed
to be critical to the successful operation of the process.
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A complete description of a critical control point must include the following five
specifications:
• Location of the control point and its parameter(s)
• Monitoring procedure for each parameter
• Frequency of monitoring
• Decision criteria for acceptable and unacceptable control
• Action to be taken if the control is unacceptable.6

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 Such a formalized procedure will ensure that proper attention will be given to the
control of a given hazard.

1.2.2 Food Hazards

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The hazards that plague the dairy processor are legion. For convenience, most of

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them can be grouped into the categories that follow. A further advantage of listing
hazards by type is that the grouping helps in their identification and suggests means
for their control. Because milk is such an excellent medium for the growth of micro-
organisms, dairy products are most susceptible to microbiological hazards.

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1.2.2.1 Microbiological Hazards
The dairy industry, much like the canners, was driven to microbiological control by
outbreaks of disease. Dating from the 19th century, such milkborne diseases as
typhoid fever, diphtheria, septic sore throat, brucellosis, and tuberculosis were wide-
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spread. By 1939 these dangers led health authorities in the United States to establish
requirements covering animal health, sanitation, pasteurization, refrigeration, and
microbiological standards.7
Modern methods for the control of foodbome disease depend on the detection of
the causative microorganism. The more significant bacteria responsible for food
poisoning have been covered in several excellent reviews.8"10 Below are summarized
the principal microorganisms of interest.
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Clostridium botulinum is responsible for the most feared form of food poisoning.
Under low-acid, anaerobic conditions this microbe will produce a toxin that is one
of the most poisonous substances known. The optimum temperature for growth and
toxin production is about 35°C (95°F). Even in minute quantities the toxin will cause
sudden death. Control of C. botulinum is made difficult because it forms spores that
are heat resistant. Any viable spores remaining in improperly canned foods will
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germinate and multiply, producing their deadly toxin. A wide variety of foods in-
cluding dairy products are susceptible to contamination. Although the toxin is heat
labile and can be made innocuous by boiling, in all instances where botulism is
suspected, the food should be discarded.
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Clostridium perfringens has been implicated in many outbreaks of food poison-

ing in the food service industry, particularly at catered events. It is most common
when food is prepared in advance and kept warm for hours before serving. Illness
is caused by a foodborne infection that results from exposure to live pathogens. With
symptoms of nausea, intestinal gas, and diarrhea, the sickness is discomforting but
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not especially serious. C. perfringens is an anaerobic, spore-forming bacteria. Al-

though it is commonly associated with meat and poultry products, this pathogen has
been found in virtually all types of processed foods.
Staphylococcus aureus is an ubiquitous organism. People are carriers of this
pathogen, which occurs in boils, skin lesions, and nasal passages. Under unsanitary
conditions, food can be contaminated with this organism which will then multiply,
producing a powerful enterotoxin that causes vomiting, cramps, and diarrhea. Be-

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 cause the toxin is heat stable and may be present after the organism is destroyed,
diagnosis of the illness can be complicated. It is important to avoid contamination
with this bacteria by maintaining personal cleanliness and adhering to recognized
sanitation procedures in the handling of foods. Refrigeration of foods below 4.4°C
(400F) inhibits the growth of this organism. Typical foods that can be adulterated

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with 5. aureus are pastries and foods of animal origin such as meats and dairy

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products.
Salmonella, of which there are more than 2000 different serotypes, is transmitted
primarily by farm animals which pass the organisms on to such foods as eggs, meat
products, poultry, and raw milk. The symptoms of salmonellosis include diarrhea,

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abdominal cramps, vomiting, and fever usually within 24 h after consuming the
contaminated food. Consequences, however, may be more severe for the very young,
the elderly, and those already weakened by disease. Salmonella is very heat sensitive,
and therefore it is readily destroyed by normal cooking of food and proper pasteur-
ization of milk. Nevertheless cross-contamination of foods after heat treatment must
be guarded against. Because Salmonella is so pervasive in nature, complete control
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of this organism has remained elusive.
Listeria monocytogenes is characterized by its ability to grow even under refrig-
eration temperatures. It is heat sensitive, however, and the preponderance of evi-
dence indicates that the microorganism is destroyed by pasteurization. Most healthy
people can survive infection, but certain individuals such as newboms, pregnant
women, and persons with impaired immune systems are particularly susceptible to
listeriosis. The mortality rate among sensitive individuals can be as high as 30 to
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40%. Raw milk and soft cheese are the dairy products most commonly associated
with listeriosis.
Campylobacterjejuni has been reported on a number of occasions when raw milk
was consumed. These incidents occurred usually under special circumstances, such
as during visits by school children to dairy farms. This organism can be controlled
by proper pasteurization.
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Yersinia enterocolitica has been the cause of serious outbreaks of food poisoning.
Such dairy products as pasteurized milk, reconstituted dry milk, and chocolate milk
were thought to have been contaminated through unsanitary handling. The afflicted
persons, many of them children, developed symptoms of intense abdominal pain
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often misdiagnosed as apendicitis. These errors resulted in a number of unnecessary

appendectomies.
Escherichia coli is common in the intestinal tract of humans and animals. As a
result it has long been used as an "indicator" organism, the presence of which in a
food product would suggest insanitation. More recent evidence indicates that certain
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strains of E. coli are pathogenic. There have been several reports of cheese contam-
inated with this organism.
Molds produce mycotoxins which may have adverse effects on humans. There-
fore care should be taken to avoid eating molds except such intentional ones as
veined in Roquefort and other blue cheeses. These organisms are capable of growth
on a variety of substrates, notably cheese among dairy products. Conditions of high
humidity and warm temperatures favor the growth of molds.

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 One toxin that has received much attention is aflatoxin, produced by the mold
Aspergillus flavus. This toxin is highly poisonous and potently carcinogenic. The
commodities peanuts, corn, and cottonseed, are most susceptible to aflatoxin con-
tamination. When contaminated feeds have been included in the rations of dairy
cows, the milk produced by these animals has been found to be adulterated with the

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toxin.

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Moldy cheese is a common occurrence and a problem that must be faced by
consumers. The normal reaction of most persons is to discard such food, but by
careful trimming, good cheese can often be recovered. Some guidelines have been
suggested for this practice:

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1. Trim only cheese that has been kept properly refrigerated.
2. If the mold growth is extensive, do not attempt to recover the cheese.
3. Consider trimming only solid cheeses; do not try to recover semisolid or soft
cheese, such as cream cheese or Brie.
4. To minimize mold growth, practice good sanitation in the handling of the cheese,
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keep it well wrapped and stored under adequate refrigeration, and consume it
within a reasonable time span.
5. Keep in mind that manufacturers' use of mold inhibitors (preservatives) such as
potassium sorbate and calcium proprionate will delay mold growth but not pre-
vent it indefinitely.11

Viruses are not a major problem with dairy products. Until the 1940s polio-
myelitis was the only viral disease known to be foodborne. This foodborne disease
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was largely associated with unpasteurized or recontaminated milk. It should be noted

that viruses cannot multiply in foods, and even the modest heat treatments of milk
pasteurization will inactivate foreseeable quantities of most viruses that might be
present.12
Somatic cells are not microbes, but their presence in milk is significant from a
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health standpoint. Somatic cells are white blood cells or body defense cells whose
primary function is to eliminate infections and repair tissue damage. Increasing num-
bers of these cells will be detected in milk from cows that are fighting off mastitis
infections. These cells are an indication of the overall health of the herd and the
quality of milk that is being produced. Thus, the goal of producers should be to
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supply milk with the lowest possible somatic cell count (SCC).13

1.2.2.2 Chemical Contamination

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Animal drug residues found in milk are a continuing health and regulatory concern.
These drugs include the sulfa drug, sulfamethazine, and such antibiotics as penicillin
and tetracycline. Concern arises because sulfa drugs have been found to cause cancer
in test animals and antibiotics may cause allergic reactions in people. A report by
the General Accounting Office, an investigative agency of Congress, was critical of
regulatory efforts and called upon the Food and Drug Administration (FDA) to take
a more active role in enforcement.14

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 The problem of drug residues is compounded by ' 'extra-label'' drug use to treat
several common diseases in dairy animals. There are few approved drugs for lac-
tating dairy animals because pharmaceutical manufacturers do not have an economic
incentive to obtain such registrations. Under the circumstances, veterinarians will
prescribe and producers will make use of drugs that are not labeled for such use.

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Generally these extralegal acts will not be prosecuted so long as certain precautions

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are taken, for example, the drug is withdrawn in sufficient time before resumption
of milking so as to avoid residue contamination. With the increasing sensitivity of
new testing methods, however, residues are being found in milk that previously
escaped detection.15

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Chemical contaminants are not limited to animal drug residues but cover a mul-
titude of other substances. These compounds include such pesticides used on crops
as dieldrin, chlordane, and heptachlor. Surveillance of Florida's milk supply has
disclosed in addition to drug residues the following chemical contaminants: vinyl
chloride, 2-4D, cyanide, lead and other heavy metals, volatile organic solvents, chlo-
rine, and acid sanitizers.16 Although some of these contaminants can be traced to
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specific infractions; others are the result of an increasing background of synthetic
substances that have pervaded our environment.
Another group of contaminants is chemical germicidals: iodophores, hypochlor-
ites, and strong ionic surfactants. These substances are used in formulations for udder
hygiene, including teat dips and washes, to control the spread of bovine mastitis.
The same germicidals are also applied to sanitize dairy process equipment. These
substances can leave toxic residues in milk.17
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1.2.2.3 Extraneous Matter

Foreign bodies such as metal filings, wooden splinters, and paint chips may be
introduced into the product through ingredients or during plant operations. Sediment
(dirt, soil) is commonly found in milk supplies and is routinely evaluated by the disk
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filtration method. Means for the detection and removal of extraneous matter will
depend on the handling characteristics of the product: whether it is in a divided state,
such as fluid and powder milk, or it is in bulk form like cheese. It is advisable to
use a combination of detection methods throughout a process.18
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1.2.2.4 Functional Hazards

Functional hazards may not pose the same dangers encountered with other hazards
but are extremely important to the dairy processor. If a product has a poor taste, a
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container is slack filled, or appearance is unappetizing, the manufacturer will surely

hear from irate customers. More to the point, sales will turn downward. Misbranding
errors will catch the attention of regulatory authorities.

1.2.3 Critical Control Points

The identification of critical control points requires a thorough familiarity with the
food process, including each step in the operation from the receiving of raw materials

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 to the shipping of finished product. A flow diagram showing all of the processing
streams is indispensable for understanding the key elements of the process. With
this knowledge at hand, a systematic search can then be made to identify the potential
entry points of each hazard. Many of these entry locations are obvious, for example,
raw materials, but others are less apparent, such as open vats, exposed conveyor

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lines, and even the equipment itself. The latter may be a source of hazards because

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of broken parts or unclean surfaces.

1.2.3.1 Blended Products

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It is instructive to take a look at a process for blended products in order to appreciate
how the critical control points are identified. Figure 1.1 shows a milk replacer proc-
ess.19 The critical control points are indicated by numbered diamonds and the other
control points by numbered circles. Complete agreement does not exist among
professionals concerning the distinction between critical control ponts and all other
control points. Some people, for example, would include as critical control points
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only those control points which monitor microbiological hazards.
Referring still to Figure 1.1, the differences between the control points can be
illustrated. Control point No. 2 might test for the protein content of the soy flour
whereas critical control point No. 2 would test for Salmonella. Critical control points
4,6, and 7 are established to check for tramp metal and other foreign objects. Critical
control point 5 monitors product uniformity whereas No. 8 is for final product testing.
Finally, critical control point 9 records the filled weights of containers.
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1.2.3.2 Raw Milk Quality

Inasmuch as milk is the common ingredient of all dairy products, its quality is key
to these products. It has been said that a milk product can be no better than the
quality of the raw materials that go into it. Because the quality of the raw milk cannot
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be improved through processing, dairy farms must provide the highest quality raw
milk from the beginning. The following controls are routinely used to evaluate the
quality of raw milk supplies.2021
Flavor, including odor, taste, mouthfeel, color, and appearance, is the most crit-
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ical attribute of raw milk. There is a consensus that flavor is the most important
yardstick for consumer acceptance of milk. Because milk flavor is so bland and mild,
the presence of any off-flavor can easily overshadow its pleasant, slightly sweet taste.
Flavor can be affected not only by the health of the dairy herd but also by the feed
composition. In spite of extensive efforts to develop instrumental analyses for flavor
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testing, the only reliable method is sensory evaluation. These screens must be con-
ducted by experienced individuals and under proper conditions, for example, the
milk sample should be tempered to 15.6 to 21.TC (60 to 700F).
Standard Plate Count (SPC) is a standardized procedure to estimate the total
aerobic, viable bacterial cell count in a sample of raw milk. Historically this test is
required by public health authorities. It also gives a good general idea of the milk
quality. Although maximum regulatory values for SPC may range from 50,000

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 WHEY SOY CALCIUM CARBONATE
1 2 3

1 2

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1/8" SCREEN 4

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5.
RIBBON BLENDER
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BAR 6
MAGNET
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SWECO 7
FILTER

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PRODUCT
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SCALE
9
PACKAGING SHIPPING
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CONTROL POINT
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CRITICAL CONTROL POINT

Figure 1.1 Milk replacer process.

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 to 100,000 per milliliter, lower counts of 20,000 per milliliter or less are highly
desirable.
Preliminary Incubation (PI) Count is a variation of the SPC test. A raw milk
sample is held for 18 h at 12.80C (55°F) before being subjected to a standard plate
count. This procedure is effective for indicating the presence of psychrotrophic or

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cold-loving bacteria. Such types of microorganisms contribute to the spoilage of the

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milk, and therefore the PI count is a good measure of shelf life. High PI counts are
evidence of sanitation shortcomings in milk production and storage. Values of PI
counts in excess of three or four times SPC are basis for rejection.
Laboratory Pasteurization Count (LPC) is obtained by subjecting raw milk

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samples to a simulated vat or batch pasteurization step, which is conducted in a
laboratory water bath. This test indicates the presence of bacteria that most likely
would survive the pasteurization process and are known as thermodurics. The legal
limit in California for LPC is 750 per milliliter.
Coliform Plate Count is obtained by using a different media from that employed
in a SPC test. It thus enumerates the group of bacteria found in the intestinal tract
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of mammals, for example, E. coli. The coliform count is a good index of the level
of sanitation. Although this test may not be used in every state for raw milk, generally
it is applied to pasteurized milk which should test at less than or equal to 10 per
milliliter.
Direct Microscopic Count (DMC) is a good screening test because the results
are obtained rapidly without plating. The DMC often provides an indication of the
cause of a sanitation problem, as the general types and range of bacteria present can
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be ascertained when a Gram stain is used. One disadvantage of the method is that
it does not differentiate dead from living bacteria, thus limiting its use with pas-
teurized milk.
Antibiotics are screened by the Bacillus subtilis or B. stearothermophilus plate
disc test. Raw milk must test no zone ^ 1 6 mm with the B. stearothermophilus disc
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assay method to comply with federal standards.

Somatic Cell Count (SCC) in excess of about 300,000 per milliliter is usually
indicative of mastitis. Somatic cells may be counted by the direct microscopic
(DMCC) procedure. The Federal standard is less than or equal to 1,000,000 per
milliliter.
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Freezing Point Determination is the standard method for ascertaining whether

raw milk has been adulterated with water. The freezing point of raw milk is sensitive
to slight changes in water content. Unadulterated raw milk has a freezing point of
=£ -0.30 0 C (31.5°F). Each increase of 0.0060C in the freezing point is indicative of
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approximately 1% added water.

Titratable Acidity (T.A.) measures the formation of lactic acid by lactic acid
bacteria due to delayed or inadequate cooling of the raw milk. Because of the buff-
ering components of milk, pH is not a practical means of determining lactic acid
formation. Excessive acid will cause a sour taste and possible milk coagulation. Low
values of T.A. are indicative of alkali producers, namely, psychrotrophs or spoilage
bacteria. Normal fresh milk exhibits a T.A. of 0.14 to 0.17% acidity (as lactic acid).

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 Sediment is determined by the disk filtration method which indicates the level
of extraneous material in the raw milk. Disks covered with the filtered sediment are
compared to standards and assigned a grade, either No. 1, 2, 3, or unlawful. Only
No. 1 and 2 grades will qualify in premium quality milk programs.
Although the above tests provide a good indication of raw milk quality, effective

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quality assurance must start with farm management. All the testing will be to no

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avail unless proper steps are adhered to by the producer. Such practices as milking,
transferring, storage, overall sanitation, and housekeeping must be tightly controlled.
No variable is more critical than the temperature of the raw milk. Regulations
require that milk be cooled to 100C (500F) within 1 h after completion of milking

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and to 7.2°C (45°F) within 2 h after milking. Preferred practice, however, is to cool
the milk to 7.2°C (45°F) within 1 h and to 4.4°C (400F) or less within 2 h. Rapid
cooling and holding the raw milk at these temperatures are vital for the maintenance
of raw milk quality. Recording thermometers are required in some states to check
compliance with these standards.
Of utmost importance to the production of quality milk is the health of dairy
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herds. Udder infections or mastitis is a continuing problem that must be controlled
in order to maximize production of the highest quality milk. The National Mastitis
Council, a nonprofit organization, assists producers in achieving these aims. This
group actively supports research and educational programs related to its objectives.22

1.2.4 Pasteurization
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Testing alone cannot ensure the absence of microorganisms in the raw milk used in
the manufacture of milk products. In dairy processes the manufacturer must take for
granted the microbiological contamination of the raw milk supply. Therefore in these
situations the processor has to depend on a "kill step" in order to eliminate or control
potentially harmful organisms. The definition of a kill step is a process adjustment
that will achieve the reproductive inactivation of a given microorganism. This kill
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step is a critical control point. In dairy processing the kill step consists of a heat
treatment known universally as pasteurization.
The principles that laid the foundation for pasteurization were first elucidated by
Louis Pasteur in the middle of the 19th century. Working with the French liquor
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industry, he showed that the development of undesirable organisms that ruined the
quality of wine could be controlled by a moderate heating step. Such a heating step
provided temperatures high enough to inactivate the harmful organisms but not so
high as to impair the taste of the wine. Subsequently this technology was adapted
to the processing of milk and has been used in this application ever since.
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1.2.4.1 Pasteurized Milk Ordinance

The Standard Milk Ordinance was introduced in 1924 by the U.S. Public Health
Service to assist states and municipalities in managing a safe milk supply. This model
regulation, now known as the Grade 64 A" Pasteurized Milk Ordinance (PMO), is
available for adoption by the more than 15,000 state, county, and local health juris-

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 dictions. The ordinance was developed and is currently updated with the assistance
of milk sanitation and regulatory officials at every level of federal, state, and local
government. These individuals are members of the National Conference on Interstate
Milk Shipments (NCIMS) which has a Memorandum of Understanding with the
FDA prescribing their joint responsibilities in protecting the nation's milk supply.

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Milk products processed under PMO are accepted as Grade A (not to be confused

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with USDA grades) and can be so labeled.
The PMO requires that only Grade A milk and milk products may be sold to the
final consumer or to restaurants, soda fountains, grocery stores, or similar establish-
ments. This requirement means that these products must be pasteurized, ultrapas-
teurized, or aseptically processed. Pasteurization is defined in the PMO as the process

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of heating every particle of milk or milk product in properly designed and operated
equipment to a specified temperature and held at that temperature for a given length
of time as indicated in Table Ll. 2 3 Ultrapasteurized means that the product shall
have been thermally processed at or above 138°C (2800F) for at least 2 s, either
before or after packaging. Aseptic processing means the product has been subjected
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to sufficient heat processing and packaged in a hermetically sealed container so as
to maintain the commercial sterility of the product under normal nonrefrigerated
conditions.
Besides providing specifications for pasteurization, the PMO gives rules govern-
ing, among other provisions, the inspection of milk haulers, tests for antibiotics,
tamper-proof caps and closures, product labeling, and sanitation practices. Former
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Table 1.1 PASTEURIZATION

CONDITIONS
Milk and Milk Products Except Eggnog

Temperature Holding Time

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a
63°C(145°F) 30 min
72°C(161°F)a 15 s
89°C (191°F) 1.0 s
90°C(194°F) 0.5 s
94°C (2010F) 0.1 s
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96°C (2040F) 0.05 s

1000C (212°F) 0.01s

Eggnog
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Temperature Holding Time

69°C (155°F) 30 min

8O0C(175°F) 25 s
83°C (180°F) 15 s
a
If the fat content of the milk product is 10% or
more, or if it contains added sweeteners, the
specified temperature shall be increased by 300C
(50F).

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 product definitions given in the PMO have been replaced by references to FDA
standards of identity, which are published in the Code of Federal Regulations (CFR).
Dairy products other than milk products are covered by separate regulations,
which provide for the pasteurization of their ingredients. Thus, the food standard for
frozen desserts including ice cream specifies that these products be produced from

l
a pasteurized mix (21CFR135.3). Cheeses and cheese products must be manufac-

ria
tured from pasteurized dairy ingredients (21CFR133.3) unless other provisions are
met. For example, in the production of Cheddar cheese, if the dairy ingredients are
not pasteurized, the cheese shall be cured at a temperature of not less than 1.7°C
(35°F) for at least 60 days (21CFR133.113).

ate
Other dairy products such as butter and nonfat dry milk are covered under USDA
grading and inspection programs. Butter, for instance, shall be made from cream
that is pasteurized at a temperature of not less than 73.9°C (165°F) for 30 min or by
other approved methods giving equivalent results (7CFR58.2622). All milk and but-"
termilk used in the manufacture of dry milk products shall be pasteurized at the plant
where dried and under conditions as specified in the regulations (7CFR58.236).
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1.2.4.2 Pasteurization Conditions
The heat treatment to which a milk product is subjected under pasteurization must
be sufficient to ensure public health safety and to ensure adequate keeping quality
of the product. At the same time the most desirable flavor and body characteristics
of the finished product should be retained. The time-temperature relations as pro-
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vided for in the PMO and other regulations are designed to meet the above criteria.
Under these conditions the microorganism Mycobacteriwn tuberculosis will be
killed. In addition, other non-spore-forming pathogens and a large percentage of the
lactic acid producers will be destroyed.
Dairy processors should keep in mind that although pasteurization devitalizes
harmful organisms, it does not destroy the toxins that may be formed in milk when
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certain staphylococci are present. Thus, the need to refrigerate milk before pasteur-
ization is clearly apparent. Proper pasteurization can be ascertained by assaying the
treated milk for its content of phosphatase, an enzyme found in raw milk. This
enzyme is more resistant to heat deactivation than any pathogen. Hence its destruc-
py

tion indicates that pasteurization has been adequate. This test is simple to run, and
it is sensitive to processing upsets.
A process called blanching has been proposed for heat-treating fresh, uncooled
raw milk. Soon after collecting, the milk is heated to 74°C (165°F) for 10 s. Although
not strictly a pasteurization process, blanching is said to provide significant control
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over milk spoilage. Using this process, farmers could reduce the frequency of milk
pickups without sacrificing quality.24 Also, a heat treatment step can be used instead
of pasteurization in certain cheese processes where pasteurization is optional. Such
a heat treatment has been found to be beneficial by controlling the development of
off-flavors.
The PMO provides considerable flexibility in the means by which pasteurization
is achieved. Three principal methods of pasteurization have been developed: batch

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 or vat pasteurization, sometimes called low-temperature holding (LTH), high-tem-
perature-short-time (HTST) pasteurization, and ultrahigh temperature (UHT) pas-
teurization. Because of their importance, each of these modes is described in some
detail below.
Batch Pasteurization is the oldest method of pasteurization, and it has the ad-

l
vantage of simplicity. Raw milk is heated in a large, closed vat by means of a steam

ria
coil or hot-water jacket. Every particle of milk, by law, must be held at 63°C (145°F)
for 30 min. An agitator keeps the milk in continuous circulation to ensure uniform
heating and to prevent the formation of a scum on the surface that would protect
bacteria by inhibiting the penetration of heat.

ate
Proper heating is assured by means of an automatic temperature controller and a
recording thermometer. In addition a mercury-indicating thermometer is required to
provide a check on the accuracy of the recording thermometer. The holding period
of 30 min does not include the time spans required for filling or emptying the vat
or the time required to bring the milk up to the required temperature. No milk shall
be added to the vat after commencement of the holding period.
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Operating experience has shown that when foam is present during pasteurization,
the temperature of the foam may be well below the pasteurization temperature. Fur-
thermore, in filling vats, milk is frequently splashed on surfaces above the milk level
as well as on the underside of the vat cover. Droplets of this splash may drip back
into the body of the milk. For the above reasons, heating of the air space above the
milk is necessary. The temperature of the air above the surface of the milk must be
kept at not less than 3°C (5°F) higher than the pasteurization temperature. To check
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on compliance with this regulation, each pasteurizer must be equipped with an air-
space recording thermometer.
All equipment used in batch pasteurization must be of sanitary design. Unless the
inlet and outlet valves as well as all connections to the vat are properly designed,
cold pockets of milk may be present during pasteurization. Precautions should also
be taken to avoid possible leaks from valves and fittings.
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High-Temperature-Short-Time (HTST) pasteurization is a continuous process

that possesses several advantages over batch pasteurization. In HTST pasteurization
the raw milk flows through a holding tube in which it is heated to 72°C (161°F) and
held at that temperature for 15 s. Higher-heat-shorter-time (HHST) pasteurization
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utilizes a temperature of 89°C (191°F) and above with holding times of 1 s and less.
HTST processing allows high volume production in a minimum of processing space.
The process also affords operating efficiencies because it uses a regenerative heater.
This heater, which simultaneously heats the raw milk and cools the pasteurized milk,
conserves energy.
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The HTST process provides additional advantages over batch pasteurization as a

result of the effects of temperature on bacterial destruction as opposed to its effects
on chemical reactions. For example, a 100C (18°F) rise in processing temperature
produces about a 10-fold increase in bacterial destruction while only doubling the
chemical reactions. (Batch pasteurization used to be conducted at 143°F or 18°F
below HTST pasteurization.) These chemical reactions are responsible for the de-
struction of certain nutrients and flavors. Therefore, the higher the temperature and

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 the shorter the processing time, the greater the retention of vitamins. Milk pasteurized
by the HTST process retains 90% of its vitamin C and 100% of its vitamin B 12
content compared with batch pasteurized milk which has none of its original vitamin
C and only 90% of its initial vitamin B 12 . Furthermore, HTST pasteurization results
in little or no loss of vitamin A, niacin, and riboflavin.25

l
The success of the HTST method of pasteurization depends on accurate, fail-safe

ria
controls. Figure 1.2 is a schematic diagram of the HTST process, showing the critical
elements of this process.26 Significant features of the system are described below.
• A constant level tank holds the cold raw milk to be pasteurized. The tank must
be equipped with controls to maintain a constant level of milk so as to provide a

ate
uniform head pressure on the milk being sucked from it by the timing pump. At all
times when the pasteurizer is in use, the tank must be covered.
• In the raw milk side of the regenerator, the cold raw milk is heated by the hot
pasteurized milk flowing in a counter-current direction on the opposite side of the
regenerator plate. The pressure of the milk flowing through the raw side of the
regenerator must always be lower than the pressure of the pasteurized milk. Thus,
dM
if any pinholes develop in the plate regenerator, pasteurized milk will leak into the
raw milk; the reverse will never occur.
• The timing pump usually is a positive displacement type that is connected to
an electric motor through a common drive shaft, gears, pulley, or variable speed
drive. The linkage and the motor controls must be sealed by the appropriate regu-
latory inspectors so that unauthorized changes cannot be made in the pump operation.
In 1982 FDA cleared the use of microprocessor-based, solid-state, AC variable-
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frequency controllers on metering pumps.27 When variable speed drives are used,
they shall be of such design that wearing or stretching of the belt results in a slow-
down rather than a speedup of the pump. In some newer pasteurization systems, the
positive displacement pump is replaced by a centrifugal pump operating in concert
with a magnetic flow meter. The signal from the flow meter will regulate either a
control valve or the speed of the pump.
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• The heater further heats the raw milk to bring it up to the pasteurization tem-
perature, namely, 72°C (161°F). The milk may be heated with steam or hot water
circulating through a plate heat exchanger.
• The holding tube must be of minimum length to hold every particle of the
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heated milk for 15 s when the timing pump is running at maximum speed. The
holding tube should have a uniform bore with a diameter of 17.8 cm (7 inches) or
less. The tube should be installed with an upward slope in the direction of flow. This
slope should be not less than 2.1 cm/m (0.25 inch/foot) in order to preclude the
entrapment of air.
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The regulations provide that the holding tube be an empty pipe. This design,
however, has a drawback, namely, product near the wall of the tube will travel
appreciably more slowly through the tube than product at the centerline. Such vari-
ation in flow rates could be reduced by installing a motionless or static mixing device
in the holding tube, thereby providing more uniform retention times.28
• An indicating thermometer and the sensor for a recorder/controller are located
downstream for the holding tube to indicate and record the temperature of the milk

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 ri
•REAKER PASTEURIZED PRODUCT
PASTEURIZED

ate
REGENERATOR COOLER I
FLOW DIVERSION RECORDER
DEVICE CONTROLLER

CONTROLLER SENSOR

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HOLDING TUBE

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RAW
DIVERT UNE REGENERATOR HEATER

RAW PRODUCT
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TIMING fUMP

f ASTEURIZED FRODUCT
CONSTANT UVEL TANK
RAW fRODUCT
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Figure 1.2 HTST pasteurizer.

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 at this point. The accuracy of the recorder/controller must be checked daily by read-
ing the indicating thermometer. The recorder/controller shall be sealed by the proper
regulatory authority.
• A flow diversion device is essentially a three-way valve used to divert any milk
not properly pasteurized back to the constant level feed tank. This device must be

l
installed not more than 46 cm (18 inches) downstream from the sensor of the re-

ria
corder/controller. The position of the flow diversion device is controlled by the
recorder/controller. The flow diversion device shall be so designed that failure of
the primary motivating power shall automatically divert the flow of the milk.
• In the pasteurized milk side of the regenerator, the pasteurized milk is partially

ate
cooled.
• The cooler further reduces the temperature of the pasteurized milk to 4°C (400F)
or below.
• An effective vacuum breaker shall be installed at least 30.5 cm (12 inches)
above the highest point reached by the raw milk in the system. This device ensures
that any flow-promoting equipment located downstream from the system will not
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create a negative pressure.
Ultrahigh Temperature (UHT) pasteurization is designed to sterilize the milk
product by killing all microorganisms present. The UHT process is capable of de-
stroying the bacterial spores of Bacillus stearothermophilis; however, certain en-
zymes present in the raw milk are many times more heat resistant. These protease
and lipase enzymes, which survive pasteurization, can initiate chemical changes that
limit shelf life.29 When UHT processed milk products are packaged in presterilized
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containers that are hermetically sealed, these products are commonly known as asep-
tically processed.
UHT pasteurization is a continuous-flow process much like HTST pasteurization
but with more sophisticated controls. By law, UHT pasteurization is defined as heat-
ing a milk product to 138°C (2800F) or higher and holding it at this temperature for
at least 2 s. Because holding times are shorter than in HTST pasteurization, greater
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care must be exercised to ensure that minimum processing conditions are being met.
The rationale for UHT processing is the dramatic increase in shelf life of the milk
product. This advantage, however, is not gained without some drawbacks. The effect
most noticeable to consumers is the change in flavor. A "cooked" flavor is initially
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formed followed after some days of storage by various stale flavors. In addition to
flavor changes, some effects on physical properties have been noted. 3031
Improvements have been sought in the UHT process to minimize its disadvan-
tages. One approach is establishing greater control over the heating method so as to
eliminate hot spots on the heat transfer surfaces and to provide for more uniform
Co

heating of the milk product. Ohmic resistance heating is one answer that has been
proposed. In this process an electric current is passed through the milk product which
is heated by means of its electrical resistance. Thus, there is no need for heat transfer
surfaces.32
Microwave pasteurization is another approach to UHT processing that has gen-
erated interest. Rapid, uniform heating can be achieved by the application of micro-
waves to a milk product. Laboratory testing has been conducted showing the effec-

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 tiveness of this method in destroying microorganisms. Nevertheless, this technology
is only at the experimental level, and considerably further research is required before
commercialization is feasible.33

l
1.2.4.3 Two Tragedies in 1985

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In spite of the many safeguards established for the pasteurization and processing of
dairy products, two tragedies associated with these products occurred in the United
States during 1985. These events, widely publicized, led to a critical reexamination
of standard practices. Out of this assessment a number of suggestions were put

ate
forward. Many of these ideas appear extremely valuable and deserve the attention
of those persons responsible for manufacturing safe products.
Toward the end of March, 1985, the Hillfarm Dairy plant in Melrose Park, Illinois,
was implicated in an outbreak of salmonellosis. Operated by Jewel Companies, Inc.,
a major supermarket chain in the Chicago area, this plant produced 2% low-fat milk,
some of which was found to be tainted. The cause of the adulteration was suspected
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to be postpasteurization contamination. Over 16,000 confirmed cases of salmonel-
losis were eventually reported. Two deaths were attributed directly to the disease
while nine other persons died from complications. The plant was shut down shortly
after the outbreak, never to be reopened, and 200 employees lost their jobs. This
epidemic was said to be the world's worst outbreak of salmonellosis ever recorded.
Not much later, in June 1985, an outbreak of listeriosis was reported in southern
California. The cause was traced to adulterated Mexican-style soft cheese, produced
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by Jalisco Mexican Products, Inc. at its plant in Artesia, a suburb of Los Angeles.
There were 142 recorded cases of listeriosis of which 47 were fatal, making this
outbreak the most deadly in United States history. Although the exact reason for the
outbreak was not determined, numerous improper procedures were uncovered during
the investigation. Most evidence indicated that raw milk had been mixed with pas-
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teurized milk or that postpasteurization contamination had occurred. Officers of the

company were found to be criminally negligent and given jail sentences. The man-
ufacturer, which had been in business for 17 years, went bankrupt, and lawsuits were
filed amounting to over $800 million.
The immediate reaction of health officials to these tragedies was to tighten en-
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forcement procedures. Clare Berryhill, director of the California Department of Food

and Agriculture, began lobbying for stricter regulations. Changes in state law were
sought to make it a felony for a plant operator to:
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• Process without pasteurization any milk product required by state regulations to

be pasteurized
• Falsify pasteurization records pertaining to thermometer readings and to mainte-
nance
• Sell milk products without being a licensed operator
• Produce soft cheese unless phosphatase tests are performed daily to ensure proper
pasteurization.34

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 The Food and Drug Administration responded with more measured steps to de-
termine what reforms, if any, might be needed. On April 1, 1986, the agency, in
cooperation with the states and industry, launched its Dairy Safety Initiative Pro-
gram, a three-part investigation comprising microbiological surveillance, check rat-
ings of interstate milk plants, and FDA inspections. Out of this effort have come

l
some preliminary assessments.

ria
In general it was noted that dairy plants are getting bigger, though there are fewer
of them, so that when contamination problems do arise, the effects are magnified.
More specifically, Sanford A. Miller, director of FDA's Center for Food Safety &
Applied Nutrition, observed, "The real problem is that plant technology is far out-
running the technology we use to assure safety."35 Jerome J. Kozak, chief of FDA's

ate
Milk Safety Branch, commented that much of the new dairy equipment needs to be
better designed for ease of cleaning and maintenance, minimizing product exposure,
and providing proper product protection. Kozak went on to outline a comprehensive
program consisting of:

1. Training and industry programs such as the Product Assurance Safety System
dM
(PASS) developed by the Milk Industry Foundation and the International Ice
Cream Association.
2. Product-safety programs in every dairy plant addressing all aspects of safety
instead of merely the "organism of today. The marriage of microbiology and
sanitation must finally be consummated."
3. Research and testing for "a pragmatic indicator organism for pathogens, rather
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than target our efforts on a selective organism."

4. Better utilization and increased effectiveness of the coliform test. "We should
establish a reduction to less than 1 coliform per ml for Grade A finished product,
and similar standards for non-Grade A products."
5. Continuance and expansion of environmental sampling by plants.
6. Continued, thorough, in-depth check ratings and inspections with the focus on
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critical control items which are "selectively regulated."

7. Consideration to establishing a National Foundation of Dairy Industry Training
and Education.36
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1.2,5 Cheese Processes

Cheese quality is affected by many factors extending back to the quality of the raw
milk used, cultures and coagulating enzymes added, methods of manufacture, and
the aging applied. Total quality control over these factors is required to produce
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products that consistently meet high standards. The necessary control points for a
typical cheese process are indicated in Figure 1.3. This flow diagram illustrates a
batch process for the production of stirred curd Cheddar cheese.37
The control points in Figure 1.3 are shown as capital letters enclosed in boxes as
follows: " C " designates a microbiological critical control point; " H " stands for
either a chemical or physical hazard critical control point; " Q " indicates a quality
control point relating to flavor, color, texture, appearance, etc.; " E " is used for an

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 VATER

MILK STORAGE PASTEURIZER

INTAKE FILTER FILTER
LACTIC
STARTER STARTER
CULTURE KESIA

l
SALT
ANNATTO

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RENNET CaCL 2
DRAIN STARTER
TABLE TANK
VHEY CHEESE
VAT
UETAL VHEY

ate
DETECTOR FINISHED
PRODUCT
SAMPLES

PACKAG- CDOLER SHIPPING

ING
VHEY
BARRELS
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Figure 1.3 Stirred curd Cheddar cheese process. (Reproduced with permission from National
Cheese Institute.)

economic control point such as yield, weight control, composition; and " R " is
reserved for a regulatory control point exemplified by labeling, coding, standards,
and weight control. The preparer of this figure has elected to include only those
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control points that are specific to the process. Other control points, of a more general
nature but still of equal importance, have been omitted. Both the control points
indicated in the figure and other selected control points are reviewed below.
• Raw milk receipts require special attention beginning with "dock tests" prior
to being unloaded. Microbiological, chemical, and physical hazards must be moni-
tored and controlled. Test procedures for many of these hazards are discussed in
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Section 1.2.3.2. In addition, incoming milk may be checked by infrared analysis for
such quality attributes as the fat-to-protein ratio. This ratio has been found to affect
both yield and quality.38 If the cheese plant is under USDA inspection, then the raw
milk intake is also a regulatory control point.
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• Ingredients other than raw milk need to be inspected. These ingredients include
water, starter media, starter culture, calcium chloride, annatto, rennet, and salt. Mi-
crobiological hazards associated with these ingredients are minimal. Research on the
growth of Listeria monocytogenes in cultures, rennet, and annatto indicated that these
ingredients would not be likely sources of contamination.39"41 The quality of these
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ingredients, however, is critical. Rennet attributes, for example, have a significant

bearing on the yield and quality of the cheese produced.42
• The milk intake line filter is a critical control point that monitors potential
physical hazards. It is also considered to be a quality control point for detecting
extraneous matter, such as hair, in incoming milk shipments.
• Milk storage has been identified as a microbiological critical control point. Milk
must be maintained at refrigerated temperatures in order to retard growth of micro-

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 organisms. A further step that has been proposed is the inoculation or preculturing
of the raw milk to control psychrotrophs.43
• The pasteurizer is labeled as a microbiological critical control point. Details of
its operation are given in Section 1.2.4.2. Aside from factors already discussed, tight
control of this point is important to minimize protein denaturization. All cheese

l
products are oil/water emulsions, which are stabilized by the natural proteins in

ria
cheese acting as surfactants. These proteins are adversely affected by processing,
particularly by the heat of pasteurization.44 The pasteurizer is also a regulatory con-
trol point inasmuch as its controls must be lead-sealed.
• Starter production is a microbiological critical control point because of the

ate
necessity of producing an active starter for subsequent rapid lactic acid development
in the cheese vat. Slow (weak) or dead starters added to the vat permit the growth
of post pasteurization microbial contamination. Starter production can be regulated
by means of automatic pH control. Starter production is also labeled a quality control
point since it affects the quality of the finished cheese.
• The cheese vat is considered to be a quality control point. At this location proper
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acidity must be developed by the starter, and curd firmness needs to be developed
through the action of the rennet.
• The metal detector is a physical hazard control point designed to pick up any
tramp metal that may be introduced at any point in the system.
• Packaging is labeled an economic control point where the packaged weight
must be checked.
• Finished product samples are taken to monitor microbiological critical control
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points, quality control points, and regulatory control points. Every vat of cheese
produced must be sampled and tested for pH because pH is critical to the control of
microbiological growth. Batches with excessively high reading of pH, above 5.4,
should be diverted to other uses, for example, pasteurized process cheese. Other
attributes that need to be checked on a periodic basis include salt content, moisture,
the percentage of milkfat, product consistency, color, flavor, extraneous matter, and
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microbiological specifications. The moisture content, for example, directly affects

shelf life.45 The meltability of the cheese is an important criterion for many appli-
cations. Development work on correlating this property to flow viscosimetry meas-
urements has been carried out.46
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• The cooler is a microbiological critical control point, as storage temperatures

are critical to the quality and safety of cheese products. As a rule, cheese is aged for
a minimum of 60 days; medium cheese for 90 to 120; and sharp cheese for 6 months
or longer. The curing temperature is reported to be held at about 4°C (39°F).47
Accelerated cheese ripening systems have been introduced in order to reduce holding
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times by as much as one half.48'49

• Shipping is shown to be the location of microbiological, chemical, and physical
critical control points. Prior to loading, each vehicle must be inspected for possible
filth and other contamination. The van temperature should comply with shipping
instructions. Shipping can be considered to be a regulatory control point as every
food manufacturer is responsible for keeping accurate shipping records that must be
made available during inspections or product recalls.

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 1.2.6 Ice Cream Processes
The Frozen Desserts Standard (2ICFR135) permits wide latitude in the manufacture
of ice cream and related products. Ice cream can be made from a large selection of
optional dairy ingredients ranging from cream and nonfat dry milk to whey and

l
sweet cream buttermilk. The variety of flavoring ingredients that may be used is

ria
almost unlimited. Any nutritive carbohydrate sweetener may be added to sweeten
the product. Unspecified functional additives, usually emulsifiers and stabilizers, may
be used at the manufacturer's discretion. Although certain minimum requirements
are established for total solids content, weight, milkfat, and nonfat milk solids, these
specifications place few constraints on producers.

ate
Given the freedom in determining product specifications, the modern ice cream
plant turns out a vast array of bulk products and frozen novelties in large quantities.
At the same time the plant is expected to achieve high efficiencies and to maintain
unmatched quality. Thanks in large part to computer technology and quality control
programs based on the HACCP principle, ice cream producers have met the chal-
lenges.50 A model of what a modern processing line looks like is illustrated in Figure
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1.4. This flow diagram shows the location of the critical control points which are
identified as follows:
1. Raw dairy product safety assessment and quality monitoring.
2. Ingredient safety assessment and quality monitoring.
3. Pasteurization standards.
4. Pasteurization equipment maintenance and inspection.
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5. Fruit preparation/straining.
6. Ingredient exposure at feeder.
7. Air quality at barrel freezer.
8. Contamination during filling/packaging.
9. Adequate sanitation and hygiene throughout the plant.51
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Because of their importance, some of these critical control points require elabo-
ration. Of considerable interest is the fact that a number of nondairy ingredients are
added to the product after pasteurization. This practice immediately flashes danger
signals. Postpasteurization contamination by microorganisms becomes a real worry.
For example, with the addition of fruits to dairy products, quality control personnel
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need to monitor not only the microbiological quality of the fruit but also the sani-
tation associated with the handling of the fruit.52
Some guidelines have been offered to govern the addition of ingredients after
pasteurization. Only those flavoring and coloring ingredients that meet the following
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qualifications may be added:

1. Subject to prior heat treatment sufficient to destroy pathogenic microorganisms
2. Of 0.85% water activity or less
3. OfpH<4.7
4. Roasted nuts (added at the freezer)
5. Contain high alcohol content
6. Bacterial cultures

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 Cnrloni and wrappers

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Dry Cold storuge
Receiving Flavor fruit and nuls

ate
lngredienu

Condensed

Cream

Corn sugar
Liquid
Cane sugar
Receiving
Water

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Milk
SANITATION
Buiier Fruit
Prepara-
tion

Distribution

Flavor and
color added
UQUlFII-R FruiU
and
nuts

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Storage
Air • 10°u>-2O 0 F
Source

Storage
tank
32° to 400P
Blending
Homogenizing Cooling Pack- Wrap-
Pasteurising Freezing Hardening
32°to 40° 2I 0 F aging ping
-45° to-5O0F
2J 0 F
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P«»p Pump
Pump P»mp

RERUN RERUN
Strainer
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Figure 1.4 Ice cream process. (Reproduced with permission from Dairy, Food and Environ-
mental Sanitation.)
Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com
 7. Fruits and vegetables added at the freezer
8. Subjected to any other process that will ensure that the ingredient is free of
pathogenic microorganisms.53
Further, it should be noted that some colorants have a history of bacterial contami-
nation requiring careful monitoring and extra precautions to ensure finished product

l
ria
safety.
Pasteurization requires some commentary. All dairy products, eggs, egg products,
cocoa, cocoa products, emulsifiers, stabilizers, liquid sweeteners, and dry sugar
should be added to the ice cream mix prior to pasteurization. In addition, all dry,
powdered, or condensed ingredients that are reconstituted with water must be added

ate
prior to pasteurization. Rerun from the freezer should be recycled to the mix ahead
of the pasteurizer, never to an intermediate point downstream, such as the flavor
tank. The pasteurization conditions are different from those for milk products. The
ice cream mix may be vat pasteurized at 69°C (155°F) for 30 min or subjected to
HTST pasteurization at 8O0C (175°F) for 25 s (21CFR135.3).
The freezing operation needs considerable attention. Barrel freezers, containing
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many intricate parts, require thorough cleaning and sanitizing. The air supply to the
freezer must be assured. Air may be drawn from either the plant environment or
from a compressed air line. Regardless of the source, the air must be free of contam-
ination by filth or microorganisms.

1.2.7 Yogurt Processes

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Yogurt processes have some of the same aspects of cheesemaking and of ice cream
production. Like cheese, yogurt is made by a culturing step. Yogurt also has some
similarity to ice cream. Sweeteners and flavoring ingredients may be added to yogurt
to increase its appeal. In addition, yogurt can be frozen to either a hard-pack or soft-
serve consistency.
The regulations define yogurt as the product of culturing cream, milk, partially
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skimmed milk, skim milk, or any combination of these dairy ingredients with the
lactic acid-producing bacteria Lactobacillus bulgaricus and Streptococcus thermoph-
ilus. (21 CFR131.200). One or more of several classes of optional ingredients may
be added, including nutritive carbohydrate sweeteners, flavoring ingredients, color
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additives, and stabilizers. The final product must have a titratable acidity of not less
than 0.9%, expressed as lactic acid. These standards, when finalized in 1981, led to
some objections from the industry which felt that they were overly restrictive.54
Some controversy surrounds a practice, used by a few producers, to heat treat the
final product in order to destroy the viable microorganisms and thereby to extend
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the shelf life of refrigerated yogurt. Although this procedure is permitted by the
regulations, many consumers and producers alike strongly feel that such a step de-
prives consumers of the potential health benefits associated with ingesting the live
organisms. These concerns led to the formation in 1986 of a nonprofit trade organi-
zation to promote the acceptance of live culture yogurt products. Known as the
National Yogurt Association, this organization has been successful in leading the
yogurt industry away from processes that heat treat the product after culturing.55

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 Yogurt is a traditional product that has its roots in antiquity. As a result it has not
always been so precisely defined as it is today.56 As in the case of other cultured
dairy products, pure laboratory starter cultures were not used to produce yogurt.
Rather, the inoculum was obtained from a previous production batch, and its micro-
biological identity was unknown. Yogurt belongs to a large class of fermented milk

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products known throughout the world. These products differ one from another by

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the source of the milk cultured, the type of starter used, and the processing condi-
tions.57 United States federal regulations recognize the diversity of cultured milk
products and, in addition to yogurt, make allowance for their production. These
products may be labeled to reflect the type of culture used, for example, *'kefir
cultured milk," or "acidophilus cultured milk" (21CFR131.112).

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To gain a better understanding of how yogurt is produced, Figure 1.5 shows a
simplified flow diagram for a yogurt process. Actual operating conditions will vary
from one producer to another, but the salient features that have been reported are
discussed below.58-59
• Dairy ingredients are blended in the right proportion so that the final yogurt
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product (but before the addition of bulky flavors) will contain not less than 3.25%
milkfat and not less than 8.25% milk-solids-not-fat, as required by the standard for
yogurt. The milkfat requirements for low-fat yogurt and for nonfat yogurt are re-
duced. In addition to the dairy ingredients, any nondairy ingredients are added to
the yogurt mix at this point. These may include a stabilizer such as gelatin and
sweeteners, typically sucrose and corn syrup solids. Only the flavoring ingredients
may be added later in the process after pasteurization.
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• The yogurt mix is pasteurized and homogenized.

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KECIIVIMO

VAT*
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BATCH
TAMKI HTIT
IL(NO
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YOOUB-I M i l

INCUBATIOM
TAMKI

nun*

Figure 1.5 Yogurt process. (Reproduced with permission from Food Engineering.)

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 • Acceptable starter cultures are necessary to produce the desired flavor and tex-
ture in the yogurt product. A microscopic check of the culture will indicate the ratio
of rods to cocci, which ideally should equal a 1:1 ratio. For a long set method of
incubation, a 2% active yogurt starter culture is used, whereas a 5% culture is needed
for the short set method.

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• Incubation may be carried out at different temperatures and holding times. For

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example, the long set method requires incubation at 32°C (900F) for approximately
18 h, and the short set method specifies 44°C (1 H 0 F) for 3 to 4 h. In either case the
process is controlled by monitoring the pH. When the final pH is reached, given in
one example as pH 3.9, the process is terminated.

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• Flavoring ingredients, commonly fruit, are added to the yogurt before filling
and packaging. The quality of the fruit is extremely important to the shelf life of the
yogurt product. In an attempt to keep yeasts and molds to an absolute minimum,
one manufacturer specifies the use on only aseptically processed fruit.
The critical control points for the yogurt process are not shown on Figure 1.5,
but they can be summarized as follows. All ingredients must be inspected, and the
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final product must be tested to meet specifications. As with other dairy processes,
pasteurization is a critical control point. In addition, pH control of the incubation
step would be considered a critical control point in order to comply with the spec-
ification for titratable acidity in the finished product.

1.2.8 Butter and Milk Processes

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In some respects butter and milk processes are the simplest of the dairy processes
under discussion. Still, the production of butter and milk products is of considerable
interest in showing how dairy processes can be integrated to achieve maximum
efficiencies. Because butter and milk processing complement each other, these prod-
ucts dovetail extremely well into a unified operation.
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An integrated butter and milk operation is illustrated in Figure 1.6. A complete

line of fluid milk products is produced, including skim milk low-fat milk, milk, and
cream. These products are designed to serve local markets. In addition, nonfat dry
milk and butter are made and sold as commodities. The key steps of this operation
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are discussed below:

• Raw milk receiving is a critical control point. Immediately on arrival a shipment
of raw milk is subjected to a battery of tests known as "dock tests" before it can
be unloaded. These tests, all of which can be performed rapidly, include titratable
acidity, antibiotic residues, flavor, temperature, and general cleanliness. The criteria
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call for a temperature of 7°C and below, and no zone r 16 mm with the Bacillus
stearothermophilus disc assay method. Many dairies use the Charm Test II for an-
tibiotics to obtain results within 10 to 12 min as opposed to 2 Vi h required with the
disc method.60
• A separator splits the raw milk into skim milk and heavy cream. This step is a
critical control point and must be closely monitored in order to ensure that milkfat
specifications will be met for all of the products produced in the plant. High-capacity,

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 ri
Spray Drier Nonfat Dry Milk

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Skim Milk
(<0.5% fat)

Lowfat Milk
Pasteurizer (1%fat)
Skim

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Milk Lowfat Milk
(2% fat)

Raw Milk Separator Blender / Milk

Homogenizer (3.25% fat)
Half and Half
36-40%

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(10.5% fat)
Cream
Pasteurizer
Light Cream
(18% fat)

Heavy Cream
(36% fat)
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Butter Butter
Churn (>80% fat)

Buttermilk
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Figure 1.6 Butter and milk processes.

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com

 sophisticated separators are available for cream separation and standardizing/
clarifying.61
• Pasteurization is required for both the skim milk and the heavy cream as elab-
orated on in Section 1.2.4.1. Pasteurization of the heavy cream used for butter
production accomplishes several purposes. This step not only destroys harmful

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microorganisms, but it also inactivates lipase enzymes which cause rancidity to de-

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velop in the butter. Proper pasteurization thus greatly increases the shelf life of the
butter produced.
• Cream is churned into butter in a revolving, barrel-type churn. Churning con-
sists of agitating the cream until the microscopic fat globules coalesce into butter

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granules. This step is a critical control point that determines whether the milkfat
specification for butter can be met (7CFR58.2621).
• Nonfat dry milk is typically produced in a spray drier which removes water in
a heated air stream. This operation is a critical control point, which ensures that the
dried milk product conforms with specification for maximum moisture content and
maximum scorched particles (7CFR58.2527). Energy efficiencies are improved by
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utilizing evaporators to concentrate the milk before spray drying.62 The severity of
the drying operation can be adjusted to produce "Low-heat," "Medium-heat," or
"High-heat" grades of nonfat dry milk (7CFR58.2539). Low-heat powders have a
minimum amount of cooked flavor and good solubility and therefore are suitable for
confections such as caramels. High-heat powders possess higher moisture-absorption
properties due to their higher content of denatured protein.63 The spray dryer is a
critical control point for yet another reason: compliance with environmental
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standards. Bag filters remove dry milk particles from the vented air stream. A reliable
detector is required to ensure the integrity of the filter.64
• Fluid milk products are produced by blending the correct proportions of skim
milk and heavy cream. Although not required except in the standard for evaporated
milk, the products are generally homogenized in order to maintain uniformity during
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storage. The blending step is a critical control point, which is required to ensure the
correct milkfat levels are present in the various products.
• Missing from Figure 1.6 is the fortification step for adding vitamin A and D
concentrates. These fat-soluble vitamins are commonly added to fluid milk products
to compensate for the amounts of these nutrients removed in the cream separation
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step. Fortification is a critical control point inasmuch as the level of addition must
be precisely controlled.65
Many dairies coproduce butter and nonfat dry milk because these products pro-
vide a "relief value" for surpluses of raw milk. In essence, they act as flywheels
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for the dairy industry, smoothing out the fluctuations in supply and demand. These
products are well qualified for this role. First, they are mutually exclusive; neither
product contains a significant amount of the other, and any dairy product can be
produced starting with some combination of the two. Second, they are storable,
having a relatively long shelf life compared to other dairy products. Holding times
exceed a year for both products. Third, their cost of manufacture is less than for
other dairy products, thus requiring less investment to carry inventory. Fourth and

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 Next Page

last, they are standardized commodities for which worldwide markets of huge di-
mensions have been created.
To achieve manufacturing efficiencies, effective control must be established over
any operation producing butter and milk products. One of the best approaches to
achieving such control is to determine milkfat balances for the entire plant. This

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procedure involves measuring the milkfat content of each stream and multiplying

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these results by the quantities of the streams. In this manner all the milkfat taken
into the plant as raw milk can be accounted for in the products produced or as losses.
In order to make the necessary milkfat balances, accurate methods of analysis are
required. The earliest test for milkfat was developed near the end of the 19th century

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by S. M. Babcock. This analytical method has been improved on by infrared analysis.
Accurate data also depend on the care taken to obtain samples. Significant variations,
for instance, have been noted in samples taken from bulk holding tanks. Finally, the
quantities or weight of each processing stream must be determined as precisely as
possible for accurate results.66
Batch processes have traditionally required considerable manual operation. This
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mode of operation has made inefficient use of personnel and has led to excessive
human errors. Because dairy processes, for the most part, are batch systems, there
has been a need for improvements in the industry. Now, some attempts have been
made to develop computer software programs for controlling batch operations. One
such program has been reported for running a fluid milk plant.67 As first steps in the
direction of total automation, dairies have installed control systems for refrigeration,
tank inventory, and clean-in-place operations.68 Progress has also been made in
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controlling individual batch operations using microprocessors.69

1.3 Product Specifications

1.3.1 Food Additives and GRAS Substances
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Food products are regulated in the United States under the Federal Food, Drug, and
Cosmetic Act. A key feature of this Act is the Food Additives Amendment of 1958,
which for the first time placed the responsibility on the food manufacturer to dem-
onstrate that all food ingredients are safe. Thus, before any new food ingredient may
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be used in food, it must be thoroughly tested by industry and an application must

be submitted to FDA.
The Amendment recognized, however, that many foodstuffs, such as milk, sugar,
and salt, have been eaten for centuries with no deleterious effects. These foods were
termed "generally recognized as safe" (GRAS) and were approved under a separate
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clause. Although there are special exceptions, food ingredients generally fall into
one of two somewhat arbitrary classifications for regulatory purposes: "food addi-
tives," which require regulatory approval in advance of use, and GRAS substances,
which are accepted outright because their safety is generally recognized as a result
of common use without perceptible harm.
Because it may not be perfectly clear whether a substance is GRAS, FDA will
consider, on request, whether or not an ingredient meets the "GRAS test." If the

Copyright © 1993 John Wiley & Sons Retrieved from: www.knovel.com