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U.S. Department of Health and Human Services |
A receiving station shall comply with Items 1p to 15p, inclusive, and 17p, 20p and 22p, except that the partitioning requirement of Item 5p shall not apply.
A transfer station shall comply with Items 1p, 4p, 6p, 7p, 8p, 9p, 10p, 11p, 12p, 14p, 15p, 17p, 20p and 22p and as climatic and operating conditions require the applicable provisions of Items 2p and 3p. Provided, that in every case, overhead protection shall be provided.
Facilities for the cleaning and sanitizing of milk tank trucks shall comply with Items 1p, 4p, 6p, 7p, 8p, 9p, 10p, 11p, 12p, 14p, 15p, 20p and 22p and as climatic and operating conditions require, the applicable provisions of Items 2p and 3p. Provided, that in every case, overhead protection shall be provided.
The floors of all rooms in which milk or milk products are handled, processed, or stored, or in which milk containers, utensils and equipment are washed, shall be constructed of concrete or other equally impervious and easily cleanable material; and shall be smooth, properly sloped, provided with trapped drains and kept in good repair. Provided, that cold-storage rooms used for storing milk and milk products need not be provided with floor drains when the floors are sloped to drain to one (1) or more exits. Provided further, that storage rooms for storing dry ingredients and/or packaging materials need not be provided with drains and the floors may be constructed of tightly joined wood.
Floors constructed of concrete or other similarly impervious material can be kept clean more easily than floors constructed of wood or other pervious or easily disintegrating material. They will not absorb organic matter and are; therefore, more apt to be kept clean and free of odors. Properly sloped floors facilitate flushing and help to avoid undesirable conditions. Trapping of drains prevents sewer gas from entering the plant.
This Item is deemed to be satisfied when:
The floors of all rooms in which milk is handled, processed, or stored or in which milk containers or utensils are washed, are constructed of good quality concrete, or equally impervious tile or brick laid closely with impervious joint material, or metal surfacing with impervious joints, or other material which is the equivalent of good quality concrete. The floors of storage rooms for dry ingredients and/or packaging material may be constructed of tightly joined wood.
The floor surface is smooth and sloped, so that there are no pools of standing water after flushing, and the joints between the floor and the walls are impervious.
The floors are provided with trapped drains. Cold-storage rooms used for storing milk and milk products need not be provided with floor drains when the floors are sloped to drain to one or more exits. Storage rooms for dry ingredients and/or packaging materials need not be provided with drains.
Walls and ceilings of rooms in which milk or milk products are handled, processed or stored, or in which milk containers, utensils and equipment are washed, shall have a smooth, washable, light-colored surface and be in good repair.
Properly finished walls and ceilings are more easily kept clean and are; therefore, more apt to be kept clean. A light-colored finish aids in the even distribution of light and the detection of unclean conditions.
This Item is deemed to be satisfied when:
Walls and ceilings are finished with smooth, washable, light-colored impervious materials.
Walls, partitions, windows and ceilings are kept in good repair.
Effective means shall be provided to prevent the access of insects and rodents. All openings to the outside shall have solid doors or glazed windows, which shall be closed during dusty weather.
Freedom from insects in the milk plant reduces the likelihood of contamination of the milk. (See Item 7r. - Public Health Reason for information on disease transmission by flies).
This item is deemed to be satisfied when:
All openings to the outer air are effectively protected by:
Screening; or
Effective electric screen panels; or
Fans or air curtains which provide sufficient air velocity so as to prevent the entrance of insects; or
Properly constructed flaps where it is impractical to use self-closing doors or air curtains; or
Any effective combination of a, b, c, or d or by any other method which prevents the entrance of insects.
All outer doors are tight and self-closing. Screen doors shall open outward.
All outer openings are rodent-proofed to the extent necessary to prevent the entry of rodents.
NOTE: The evidence of insects and/or rodents in the plant shall be considered under Item 9p.
All rooms in which milk or milk products are handled, processed or stored and/or in which milk containers, utensils and equipment are washed shall be well lighted and well ventilated.
Ample light promotes cleanliness. Proper ventilation reduces odors and prevents condensation upon interior surfaces.
This Item is deemed to be satisfied when:
Adequate light sources are provided (natural, artificial or a combination of both) which furnish at least twenty (20) foot-candles of light in all working areas. This shall apply to all rooms where milk or milk products are handled, processed or stored, or where containers, utensils and/or equipment are washed. Dry storage and cold storage rooms shall be provided with at least five (5) foot-candles of light.
Ventilation in all rooms is sufficient to keep them reasonably free of odors and excessive condensation on equipment, walls and ceilings.
Pressurized ventilating systems, if used, have a filtered air intake.
There shall be separate rooms for:
The pasteurizing, processing, cooling and packaging of milk and milk products.
The cleaning of milk cans, bottles and cases.
The fabrication of containers and closures for milk and milk products.
Cleaning and sanitizing facilities for milk tank trucks in plants receiving milk in such tanks.
Receiving cans of milk and milk products in plants receiving such cans.
Rooms in which milk or milk products are handled, processed or stored, or in which milk containers, utensils and equipment are washed or stored, shall not open directly into any stable or any room used for domestic purposes. All rooms shall be of sufficient size for their intended purposes.
Designated areas or rooms shall be provided for the receiving, handling and storage of returned packaged milk and milk products.
If the washing and sanitization of containers are conducted in the same room in which the pasteurizing, processing, cooling or packaging is done, there is opportunity for the pasteurized product to become contaminated. For this reason, separate rooms are required as indicated. The unloading of cans of raw milk directly into the pasteurizing room is apt to increase the prevalence of insects therein, as well as to render it too public.
This Item is deemed to be satisfied when:
Pasteurizing, processing, cooling and packaging are conducted in a single room(s), but not in the same room(s) used for the cleaning of milk cans, bottles and cases, or the unloading and/or cleaning and sanitizing of milk tank trucks. Provided, that cooling, plate or tubular, may be done in the room where milk tank trucks are unloaded and/or cleaned and sanitized. Separation/clarification of raw milk may be done in an enclosed room where tank trucks are unloaded and/or cleaned and sanitized.
All returned packaged milk and milk products, which have physically left the premises of the processing plant, shall be received, handled and stored in separate areas or rooms isolated from the Grade "A" dairy operations. Such separate areas or rooms shall be clearly defined and marked for such use.
All bulk milk storage tanks are vented into a room used for pasteurization, processing, cooling or packaging operations, or into a storage tank gallery room. Provided, that vents located elsewhere which are adequately equipped with air filters so as to preclude the contamination of the milk, shall be considered satisfactory.
Facilities for the cleaning and sanitizing of milk tank trucks are properly equipped for manual and/or mechanical operations. When such facilities are not provided on the plant premises, these operations shall be performed at a receiving station, transfer station or separate milk tank truck cleaning facility. Items relating to facilities for cleaning and sanitizing milk tank trucks are listed at the beginning of this Section.
Rooms in which milk or milk products are handled, processed or stored, or in which milk containers, utensils and equipment are washed or stored, do not open directly into any stable or any room used for domestic purposes.
All rooms shall be of sufficient size for their intended purposes.
Every milk plant shall be provided with toilet facilities conforming to the regulations of the ... of ...1 Toilet rooms shall not open directly into any room in which milk and/or milk products are processed. Toilet rooms shall be completely enclosed and shall have tight-fitting, self-closing doors. Dressing rooms, toilet rooms and fixtures shall be kept in a clean condition, in good repair and shall be well ventilated and well lighted. Sewage and other liquid wastes shall be disposed of in a sanitary manner.
Human excreta are potentially dangerous and must be disposed of in a sanitary manner. The organisms causing typhoid fever, para-typhoid fever and dysentery may be present in the body discharges of active cases or carriers. Sanitary toilet facilities are necessary to protect the milk, equipment and containers from fecal contamination, which may be carried by flies, other insects, hands or clothing. When the toilet facilities are of a satisfactory type, are kept clean and are in good repair, the opportunities for the spread of contamination by the above means are minimized. The provision of an intervening room or vestibule between the toilet room and any room in which milk or milk products are processed makes it less likely that contaminated flies will enter these rooms. It will also minimize the spread of odors.
The wastes resulting from the cleaning and rinsing of containers, equipment and floors, from flush toilets, and from washing facilities, should be properly disposed of so as not to contaminate the milk equipment, or to create a nuisance or a public health hazard.
This Item is deemed to be satisfied when:
The milk plant is provided with toilet facilities conforming to the regulations of the ... of ...1
Toilet rooms do not open directly into any room in which milk and/or milk products are processed.
Toilet rooms are completely enclosed and have tight-fitting, self-closing doors.
Dressing rooms, toilet rooms and fixtures are kept in a clean condition, in good repair and are well ventilated and well lighted.
Toilet tissue and easily cleanable covered waste receptacles are provided in toilet rooms.
All plumbing is installed to meet the applicable provisions of the State or local plumbing code.
Sewage and other liquid wastes are disposed of in a sanitary manner.
Non-water-carried sewage disposal facilities are not used.
Water for milk plant purposes shall be from a supply properly located, protected and operated and shall be easily accessible, adequate and of a safe, sanitary quality.
The water supply should be accessible in order to encourage its use in cleaning operations; it should be adequate so that cleaning and rinsing may be thorough; and it should be of a safe, sanitary quality in order to avoid the contamination of milk equipment and containers.
This Item is deemed to be satisfied when:
Water for milk plant purposes is from an adequate supply, properly located, protected and operated. It shall be easily accessible and of a safe, sanitary quality.
The water supply is approved as safe by the State Water Control Authority and, in the case of individual water systems, complies with the specification outlined in Appendix D. and the Bacteriological Standards outlined in Appendix G.
There is no cross-connection between the safe water supply and any unsafe or questionable water supply, or any source of pollution through which the safe water supply might become contaminated. A connection between the water supply piping and a make-up tank, such as for cooling or condensing, unless protected by an air gap or effective backflow preventer, constitutes a violation of this requirement.
Condensing water for milk evaporators, and water used to produce vacuum and/or to condense vapors in vacuum heat processing equipment, is from a source complying with Item 2. above. Provided, that when approved by the Regulatory Agency, water from sources not complying with Item 2. above, may be used when the evaporator or vacuum heat equipment is constructed and operated to preclude contamination of such equipment, or its contents, by condensing water or by water used to produce vacuum. Means of preventing such contamination are:
Use of a surface type condenser in which the condensing water is physically separated from the vapors and condensate; or
Use of reliable safeguards to prevent the overflow of condensing water from the condenser into the evaporator. Such safeguards include a barometric leg extending at least thirty-five (35) feet vertically from the invert of the outgoing condensing water line to the free level at which the leg discharges, or a safety shutoff valve, located on the water feed line to the condenser, automatically actuated by a control which will shut off the in-flowing water when the water level rises above a predetermined point in the condenser. This valve may be actuated by water, air or electricity, and shall be designed so that failure of the primary motivating power will automatically stop the flow of water into the condenser.
Condensing water for all milk evaporators, complying with Item 2. above, and water reclaimed from milk or milk products may be reused when all necessary means of protection are afforded and it complies with the procedures outlined in Appendix D., Part V.
New individual water supplies and water supply systems, which have been repaired or otherwise become contaminated, are disinfected before being placed in use. (See Appendix D.) The supply shall be made free of the disinfectant by pumping to waste before any sample for bacteriological testing shall be collected.
Samples for bacteriological testing of individual water supplies are taken upon the initial approval of the physical structure; each six (6) months thereafter; and when any repair or alteration of the water supply system has been made. Samples shall be taken by the Regulatory Agency and examinations shall be conducted in an official laboratory. To determine if water samples have been taken at the frequency established in this Section, the interval shall include the designated six (6) month period plus the remaining days of the month in which the sample is due.
Current records of water test results are retained on file with the Regulatory Agency or as the Regulatory Agency directs.
Convenient handwashing facilities shall be provided, including hot and cold and/or warm running water, soap and individual sanitary towels or other approved hand drying devices. Handwashing facilities shall be kept in a clean condition and in good repair.
Proper use of handwashing facilities is essential to personal cleanliness and reduces the likelihood of contamination of milk and milk products.
This Item is deemed to be satisfied when:
Convenient handwashing facilities are provided, including hot and cold and/or warm running water, soap and individual sanitary towels or other approved hand-drying devices.
Handwashing facilities are convenient to all toilets and to all rooms in which milk plant operations are conducted.
Handwashing facilities are kept in a clean condition and in good repair.
Steam-water mixing valves and vats for washing bottles, cans and similar equipment are not used as handwashing facilities.
All rooms in which milk and milk products are handled, processed or stored, and/or in which containers, utensils or equipment are washed or stored, shall be kept clean, neat and free of evidence of insects and rodents. Only equipment directly related to processing operations or the handling of containers, utensils and equipment shall be permitted in the pasteurizing, processing, cooling, packaging and bulk milk storage rooms.
Clean floors, free of litter, clean walls, ceilings and all other areas of the dairy plant are conducive to clean milk handling operations. Cleanliness and freedom from insects and rodents reduces the likelihood of contamination of the milk or milk product. Excess or unused equipment or equipment not directly related to the dairy plant operations can be detrimental to the cleanliness of the dairy plant.
This Item is deemed to be satisfied when:
Only equipment directly related to processing operations or the handling of containers, utensils and equipment is permitted in the pasteurizing, processing, cooling, packaging and bulk milk storage rooms.
All piping, floors, walls, ceilings, fans, shelves, tables and the non-product-contact surfaces of other facilities and equipment are clean.
No trash or solid waste is stored within the plant, except in covered containers. Waste containers at the packaging machine or bottle washer may be uncovered during the operation of such equipment.
All rooms in, which milk and milk products are handled, processed or stored, and/or in which containers, utensils, or equipment are washed or stored, are kept clean, neat and free of evidence of insects and rodents.
All sanitary piping, fittings and connections which are exposed to milk or milk products, or from which liquids may drip, drain or be drawn into milk or milk products, shall consist of smooth, impervious, corrosion-resistant, nontoxic, easily cleanable material which is approved for food contact surfaces. All piping shall be in good repair. Pasteurized milk and milk products shall be conducted from one piece of equipment to another only through sanitary piping.9
Milk piping and fittings are sometimes so designed as to be difficult to clean, or they may be constructed of metal, which corrodes easily. In either case, it is unlikely that they will be kept clean. Sanitary milk piping is a term, which applies to properly designed and properly constructed piping.
The purpose of the third sentence is to prevent exposure of the pasteurized product to contamination.
This Item is deemed to be satisfied when:
All sanitary piping, fittings and connections which are exposed to milk or milk products, or from which liquids may drip, drain or be drawn into milk products, consist of smooth, impervious, corrosion-resistant, nontoxic, easily cleanable material.
All sanitary piping, connections and fittings consist of:
Stainless steel of the AISI 300 series; or
Equally corrosion-resistant metal which is nontoxic and nonabsorbent; or
Heat resistant glass; or
Plastic, or rubber and rubber-like materials which are relatively inert, resistant to scratching, scoring, decomposition, crazing, chipping and distortion under normal use conditions; are nontoxic, fat resistant, relatively nonabsorbent; which do not impart flavor or odor to the product; and which maintain their original properties under repeated use conditions, may be used for gaskets, sealing applications and for short flexible takedown jumpers or connections where flexibility is required for essential or functional reasons.
Sanitary piping, fittings and connections are designed to permit easy cleaning; kept in good repair; free of breaks or corrosion; and contain no dead ends of piping in which milk may collect.
All interior surfaces of demountable piping, including valves, fittings and connections are designed, constructed and installed to permit inspection and drainage.
All mechanically cleaned milk pipelines and return-solution lines are rigid, self-draining and so supported to maintain uniform slope and alignment. Return solution lines shall be constructed of material meeting the specifications of Item 2. above. If gaskets are used, they shall be self-positioning, of material meeting the specifications outlined in Item 2. above and designed, finished and applied to form a smooth, flush interior surface. If gaskets are not used, all fittings shall have self-positioning faces designed to form a smooth, flush interior surface. All interior surfaces of welded joints in pipelines shall be smooth and free from pits, cracks or inclusions.
In the case of welded lines, all welds shall be inspected as they are made and such welds shall be approved by the Regulatory Agency.
Each cleaning circuit shall have access points for inspection in addition to the entrances and exits. These may be valves, removable sections, fittings or other means or combinations that are adequate for the inspection of the interior of the line. These access points shall be located at sufficient intervals to determine the general condition of the interior surfaces of the pipeline.
Detailed plans for welded pipeline systems shall be submitted to the Regulatory Agency for written approval prior to installation. No alteration or addition shall be made to any welded milk pipeline system without prior written approval from the Regulatory Agency.
Pasteurized milk and milk products are conducted from one piece of equipment to another only through sanitary milk piping.
All multi-use containers and equipment that milk or milk products come into contact with shall be of smooth, impervious, corrosion-resistant, nontoxic material; shall be constructed for ease of cleaning; and shall be kept in good repair. All single-service containers, closures, gaskets and other articles that milk or milk products come in contact with shall be nontoxic and shall have been manufactured, packaged, transported and handled in a sanitary manner. Articles intended for single-service use shall not be reused.
When equipment is not constructed and located so that it can be cleaned easily, and which is not kept in good repair, it is unlikely that it will be properly cleaned.
Single-service articles, which have not been manufactured and handled in a sanitary manner, may contaminate the milk.
This Item is deemed to be satisfied when:
All multi-use containers and equipment that milk or milk products come into contact with are of smooth, impervious, corrosion-resistant and nontoxic material.
All milk-contact surfaces of multi-use containers and equipment consist of:
Stainless steel of the AISI 300 series; or
Equally corrosion-resistant metal which is nontoxic and nonabsorbent; or
Heat resistant glass; or
Plastic or rubber and rubber-like materials which are relatively inert, resistant to scratching, scoring, decomposition, crazing, chipping and distortion under normal use conditions; which are nontoxic, fat resistant, relatively nonabsorbent and do not impart flavor or odor to the product; and which maintain their original properties under repeated use conditions.
All joints in containers, utensils and equipment are flush and finished as smooth as adjoining surfaces. Where a rotating shaft is inserted through a surface with which milk or milk products come into contact, the joint between the moving and stationary surfaces shall be close fitting. Where a thermometer or temperature-sensing element is inserted through a surface, with which milk or milk products come into contact, a pressure-tight seal shall be provided ahead of all threads and crevices.
All openings in covers of tanks, vats, separators, etc. are protected by raised edges, or otherwise, to prevent the entrance of surface drainage. Condensation-diverting aprons shall be provided as close to the tank or vat as possible on all pipes, thermometers, or temperature sensing elements and other equipment extending into a tank, bowl, vat or similar equipment, unless a watertight joint is provided.
All surfaces with which milk or milk products come into contact are easily accessible or demountable for manual cleaning or are designed for mechanical cleaning. All product-contact surfaces shall be readily accessible for inspection and shall be self-draining.
There are no threads used in contact with milk or milk products except where needed for functional and safety reasons, such as in clarifiers, pumps and separators. Such threads shall be of a sanitary type.
All multi-use containers and other equipment have rounded corners; are in good repair; and free from breaks, crevices and corrosion. Milk cans shall have umbrella-type covers.
Strainers, if used, are of perforated metal design and so constructed as to utilize single-service strainer media. Multiple-use, woven material shall not be used for straining milk. Provided, that when required for functional reasons inherent to the production of certain milk products, such as buttermilk, whey and dry milk products, woven material may be used where it is impractical to use perforated metal. However, woven material parts shall be mechanically cleaned by such methods that thoroughly clean the woven material and do not contaminate the product.
All single-service containers, closures, gaskets and other articles that milk or milk products come in contact are nontoxic.
The manufacture, packing, transportation and handling of single-service containers, closures, caps, gaskets and similar articles comply with the requirements of Appendix J., Standards for the Fabrication of Single-Service Containers and Closures for Milk and Milk Products. Inspections and tests shall be made by the Regulatory Agency or any agency authorized by them.
NOTE: 3-A Sanitary Standards for dairy equipment are promulgated jointly by the Sanitary Standards Subcommittee of the Dairy Industry Committee, the Committee on Sanitary Procedure of the International Association for Food Protection and the Milk Safety Branch, Center for Food Safety and Applied Nutrition, Food and Drug Administration, Public Health Service, Department of Health and Human Services. Equipment manufactured in conformity with 3-A Sanitary Standards complies with the sanitary design and construction standards of this Ordinance.
The product-contact surfaces of all multi-use containers, utensils and equipment used in the transportation, processing, handling and storage of milk or milk products shall be effectively cleaned and shall be sanitized before each use. Provided, that piping, equipment and containers used to process, conduct or package aseptically processed milk and milk products, beyond the final heat treatment process, shall be sterilized before any aseptically processed milk or milk product is packaged and shall be resterilized whenever any unsterile product has contaminated it.
Milk and milk products cannot be kept clean and safe, if permitted to come into contact with containers, utensils and equipment that have not been properly cleaned and sanitized.
This Item is deemed to be satisfied when:
All multi-use containers and utensils are thoroughly cleaned after each use and all equipment is thoroughly cleaned at least once each day used unless FDA and the Regulatory Agency have reviewed and accepted information supporting the cleaning of multi-use containers and utensils at frequencies extending beyond one (1) day or seventy-two (72) hours in the case of storage tanks. Supporting information shall be submitted to and approved by the Regulatory Agency in consultation with FDA prior to initiating the qualification period if required. Finished product produced during an extended run must meet all applicable requirements of Section 7. Any significant equipment or processing changes shall be communicated to the Regulatory Agency. The supporting information may include but is not limited to:
Statement of proposal, including desired cleaning frequency;
Product and equipment description;
Intended use and consumers;
Distribution and storage temperatures of product;
Diagram of process of interest;
Process parameters, including temperature and times;
Hazard evaluation and safety assessment;
Review of equipment for sanitary design; and
When indicated by a hazard evaluation and safety assessment, a plan for initial qualification shall be developed to address identified critical process parameters.
Otherwise, storage tanks shall be cleaned when emptied and shall be emptied at least every seventy-two (72) hours. Records must be available to verify that milk storage in these tanks does not exceed seventy-two (72) hours. These records shall be available for at least the previous three (3) months or from the time of the last regulatory inspection, whichever is longer. In the case of pasteurized storage tanks, which are mechanically cleaned at intervals of less than seventy-two (72) hours, the mechanical cleaning records required under Item 2.b. of this Section shall be considered adequate. Storage tanks, which are used to store raw milk or heat-treated milk products longer than twenty-four (24) hours and silo tanks used for the storage of raw milk or heat-treated milk products shall be equipped with a seven (7) day temperature recording device complying with the specifications of Appendix H.
Whenever a milk tank truck has been cleaned and sanitized, as required by the Regulatory Agency, it shall bear a tag or a record shall be made showing the date, time, place and signature or initials of the employee or contract operator doing the work, unless the truck delivers to only one receiving unit where responsibility for cleaning and sanitizing can be definitely established without tagging. The tag shall be removed at the location where the tank truck is next washed and sanitized and kept on file for fifteen (15) days as directed by the Regulatory Agency.
Pipelines and/or equipment designed for mechanical cleaning meet the following requirements:
An effective cleaning and sanitizing regimen for each separate cleaning circuit shall be followed.
A temperature recording device, complying with the specifications in Appendix H., or a recording device which provides sufficient information to adequately evaluate the cleaning and sanitizing regimen and which is approved by the Regulatory Agency, shall be installed in the return solution line or other appropriate area to record the temperature and time which the line or equipment is exposed to cleaning and sanitizing solutions. For purposes of this Section, recording devices which produce records not meeting the specifications of Appendix H. may be acceptable if:
(1) The device provides a continuous record of the monitoring of the cleaning cycle time and temperature, cleaning solution velocity or cleaning pump operation and the presence or strength of cleaning chemicals for each cleaning cycle.
(2) The record shows a typical pattern of each circuit cleaned, so that changes in the cleaning regimen may be readily detected.
(3) Electronic storage of required cleaning records, with or without hard copy printouts, may be acceptable, provided, the electronically generated records are readily available. Electronic records must meet the criteria of this Section and those provisions of Appendix H., which are determined to be applicable by the Regulatory Agency and FDA.
Cleaning charts and electronically stored records required by this Section shall be identified, dated and retained for three (3) months or until the next regulatory inspection, whichever is longer.
During each official inspection, the Regulatory Agency shall examine charts and records to verify the cleaning regimens.
Plants in which containers are washed manually are equipped with a two (2)-compartment wash-and-rinse vat for this purpose. Such plants shall also provide a steam cabinet or individual steam-jet plate with hood for sanitizing of cleaned containers, or if sanitizing is done with chemicals, a third treatment vat.
In plants utilizing automatic bottle washers, such washers must provide for
bactericidal treatment by means of steam, hot water or chemical treatment. In soaker-type
bottle washers, in which bactericidal treatment depends upon the causticity of the washing
solution, the caustic strength for a given soaking time and temperature shall be as specified
in the following table which lists the combinations of causticity, time and temperature, of
equal bactericidal value, for the soaker tank of soaker-type bottle washers:
| Temperature, Degrees | |||||||
|---|---|---|---|---|---|---|---|
| C | 77 | 71 | 66 | 60 | 54 | 49 | 43 |
| F | 170 | 160 | 150 | 140 | 130 | 120 | 110 |
| Time in Minutes | Concentration of NaOH (percent) | ||||||
| 3 | 0.57 | 0.86 | 1.28 | 1.91 | 2.86 | 4.27 | 6.39 |
| 5 | 0.43 | 0.64 | 0.96 | 1.43 | 2.16 | 3.22 | 4.80 |
| 7 | 0.36 | 0.53 | 0.80 | 1.19 | 1.78 | 2.66 | 3.98 |
| NOTE: The National Soft Drink Association (NSDA), Washington, D.C. 20036 alkali test, the NSDA caustic test, or other suitable test may be used to determine the strength of the soaker solution. The caustic strength shall be tested monthly by the Regulatory Agency. | |||||||
When caustic is so used, subsequent final rinsing of the bottles shall be with water, which has been treated with heat or chemicals to assure freedom from viable pathogenic or otherwise harmful organisms, to prevent recontamination of the treated bottle during the rinsing operation.
All multi-use containers, utensils and equipment are sanitized before use, employing one or a combination of the methods prescribed under Item 11r. Assembled equipment must be sanitized prior to each day's run, unless FDA and the Regulatory Agency have reviewed and accepted information supporting the sanitizing of multi-use containers, utensils and equipment at frequencies extending beyond one (1) day. Tests to determine the efficiency of sanitization should be made by the Regulatory Agency at intervals sufficient to satisfy the Regulatory Agency that the sanitization process is effective. Provided, that all piping, equipment and containers used to conduct, process or package aseptically processed milk and milk products, beyond the final heat treatment process, shall be sterilized by heat, chemical sterilant(s) or other appropriate treatment before use and resterilized whenever it has been contaminated by unsterile product.
a. The residual bacteria count of multi-use containers and closures shall be conducted as outlined in Appendix J. The residual bacteria count of multi-use containers, used for packaging pasteurized milk and milk products, shall not exceed one (1) organism per milliliter (1/mL) of capacity, when the rinse test is used, or not over fifty (50) colonies per fifty (50) square centimeters (one (1) colony per square centimeter) of product-contact surface, when the swab test is used, in three (3) out of four (4) samples taken at random on a given day. All multi-use containers shall be free of coliform organisms.
b. The residual bacteria count of single-service containers and closures, used for packaging pasteurized milk and milk products, shall not exceed fifty (50) per container, when the rinse test is used, except that in containers less than 100 mL, the count shall not exceed ten (10) or not over fifty (50) colonies per eight (8) square inch (one (1) colony per square centimeter) of product-contact surface, when the swab test is used, in three (3) out of four (4) samples taken at random on a given day. All single-service containers shall be free of coliform organisms.
When single-service containers or closures are fabricated in another plant that conforms to the Standards of Appendix J. and the Regulatory Agency has information that they do comply, the Regulatory Agency may accept the containers as being in conformance without additional tests. If there is reason to believe that containers do not conform to the bacteriological standards, additional tests may be required. If containers are fabricated in the dairy plant, the Regulatory Agency shall collect at least four (4) sets of containers, each (6) months, and determine conformance.
Plants that utilize multi-use plastic containers, for pasteurized milk and milk products, shall comply with the following criteria:
All containers shall be identified as to plant of manufacture, date of manufacture and type and class of plastic material used. This information may be by code. Provided, that the code is revealed to the Regulatory Agency.
A device shall be installed in the filling line capable of detecting, in each container before it is filled, volatile organic contaminants in amounts that are of public health significance. Such device must be constructed so that it may be sealed by the Regulatory Agency to prevent the changing of its sensitivity functioning level. Models using an air injection system and with a testing device built into the detection equipment do not have to be sealed. To assure proper functioning of the system the operator needs to be able to adjust the sensitivity. However, those models utilizing an external testing device must be sealed. Any container detected by the device, as being unsatisfactory must be automatically made unusable to prevent refilling. In addition, the device must be interconnected so that the system will not operate unless the detecting device is in proper operating condition. Provided, that any other system so designed and operated that will provide equal assurance of freedom from contamination and recognized by FDA to be equally efficient may be accepted by the Regulatory Agency.
A standard must be available for use by the Regulatory Agency for testing the proper sensitivity functioning levels of the detection device.
The containers shall comply with the applicable construction requirements of Item 11p. of this Ordinance. The closure for the container shall be single-service. Screw-type closures shall not be used.
The container shall not impart, into the product, pesticide residual levels or other chemical contaminants in excess of those considered acceptable under the FFD&CA and regulations issued thereunder.
The phrase "Use only for food" shall appear on all containers.
After cleaning, all multi-use milk or milk product containers, utensils and equipment shall be transported and stored to assure complete drainage and shall be protected from contamination before use.
If containers and equipment are not protected from contamination, the value of sanitization may be partly or entirely nullified.
This Item is deemed to be satisfied when:
All multi-use containers, utensils and equipment, after cleaning, are transported and/or stored on racks made of impervious food grade materials, or in clean cases elevated above the floor. Containers shall be stored inverted on racks or in cases constructed of relatively nonabsorbent, impervious, food-grade, corrosion-resistant, nontoxic materials, or otherwise protected from contamination.
Single-service caps, cap stock, parchment paper, containers, gaskets and other single-service articles for use in contact with milk and milk products shall be purchased and stored in sanitary tubes, wrappings or cartons; shall be kept therein in a clean, dry place until used; and shall be handled in a sanitary manner.
Soiled or contaminated caps, parchment paper, gaskets and single-service containers nullify the benefits of the safeguards prescribed throughout this Ordinance. Packing the caps in tubes, which remain unbroken until they are placed in the bottling machine, is the best method of assuring cap cleanliness.
This Item is deemed to be satisfied when:
Single-service caps, cap stock, parchment paper, containers, gaskets and other single-service articles for use in contact with milk and milk products are purchased and stored in sanitary tubes, wrappings or cartons; are kept in a clean, dry place until used; and are handled in a sanitary manner.
Paperboard shipping containers used to enclose plastic bags or unfilled containers are used only once, unless other methods are employed to protect the containers from contamination.
Tubes or cartons are not refilled with spilled caps, gaskets or parchment papers.
Cartons or boxes from which contents have been partially removed are kept closed.
Suitable cabinets are provided for storage of tubes after removal from the large outer box, and for storage of opened cartons, unless other satisfactory means are employed to protect the caps, closures or containers.
Milk plant operations, equipment and facilities shall be located and conducted to prevent any contamination of milk or milk products, ingredients, containers, utensils and equipment. All milk or milk products or ingredients that have been spilled, overflowed or leaked shall be discarded. The processing or handling of products other than milk or milk products in the pasteurization plant shall be performed to preclude the contamination of such milk and milk products. The storage, handling and use of poisonous or toxic materials shall be performed to preclude the contamination of milk and milk products, or ingredients of such milk and milk products or the product-contact surfaces of all containers, utensils and equipment.
Because of the nature of milk and milk products and their susceptibility to contamination by bacteria, chemicals and other adulterants, every effort should be made to provide adequate protection for the milk and milk products at all times. Misuse of pesticides and other harmful chemicals can provide opportunities for contamination of the milk, milk product or equipment with which the milk or milk product comes in contact.
This Item is deemed to be satisfied when:
Equipment and operations are so located within the plant as to prevent overcrowding and contamination of cleaned and sanitized containers, utensils and equipment by splash, condensation or manual contact.
Packaged milk and milk products which have physically left the premises or the processing plant are not repasteurized for Grade "A" use. The Regulatory Agency may, on a specific individual request, authorize reprocessing of packaged milk and milk products, provided all other aspects of this Item, including proper storage temperature and container integrity are complied with. Provided, that the repasteurization of milk and milk products shipped in transport milk tank trucks which have been pasteurized at another Grade "A" plant and have been handled in a sanitary manner and maintained at 7°C (45°F) or less is permitted. Equipment, designated areas or rooms utilized for handling, processing and storage of returned packaged milk and milk products are maintained, operated, cleaned and sanitized so as to preclude contamination of Grade "A" products and equipment and the Grade "A" operations.
All product-contact surfaces of containers, utensils and equipment are covered or otherwise protected to prevent the access of insects, dust, condensation and other contamination. All openings, including valves and piping attached to milk storage and milk tank trucks, pumps, vats, etc., shall be capped or otherwise properly protected. While unloading at a pasteurization plant, receiving station or transfer station, one of the following conditions shall be met:
If the area is completely enclosed, walls and ceiling, with doors closed during the unloading process and the dust-cover or dome and the manhole cover is opened slightly and held in this position by the metal clamps used to close the cover, then a filter is not required. However, if the dust cover and/or manhole cover(s) are opened in excess of that provided by the metal clamps or the covers have been removed, then a suitable filter is required for the manhole.
If the area is not completely enclosed or doors of the unloading area are open during unloading, a suitable filter is required for the manhole or air inlet vent and suitable protection must be provided over the filter material either by design of the filter holding apparatus or a roof or ceiling over the area. When weather and environmental conditions permit, manhole openings and covers of milk tank trucks may be opened outdoors for the short period of time necessary for the collection of samples for animal drug residue screening. Direct connections from milk tank truck to milk tank truck must be made from valve-to-valve or through the manhole lid. Provided, that all connections are made ferrule-to-ferrule and adequate protection is provided for the air vent.
Receiving and dump vats shall be completely covered, except during washing and sanitizing, and when milk is being dumped. Where strainers are used, the cover for the vat opening shall be designed to cover the opening with the strainer in place.
Whenever air under pressure is used for the agitation or movement of milk, or is directed at a milk-contact surface, it is free of oil, dust, rust, excessive moisture, extraneous materials and odor, and shall otherwise comply with the applicable standards of Appendix H. The use of steam containing toxic substances is expressly prohibited. Whenever steam is used in contact with milk or milk products, it shall be of culinary quality and shall comply with the applicable standards of Appendix H.
Standardization of Grade "A" milk and milk products with other than Grade "A" milk and milk products is prohibited. This Ordinance permits standardization as a process of adjusting the milkfat of milk in a milk plant by the addition or removal of cream or non-fat (skim) milk.
All multi-use cases used to encase packaged milk and milk product containers are cleaned prior to their use.
All ingredients and non-product-contact materials used in the preparation or packaging of milk and milk products are stored in a clean place and are so handled as to prevent their contamination.
Pasteurized milk is not strained or filtered, except through a perforated metal strainer.
Only those poisonous or toxic materials, including but not limited to insecticides, rodenticides, detergents, sanitizers, caustics, acids, related cleaning compounds and medicinal agents necessary for the maintenance of the dairy plant are present in the dairy plant.
Those poisonous or toxic materials that are necessary are not stored in any room where milk or milk products are received, processed, pasteurized or stored; or where containers, utensils or equipment, are washed; or where single-service containers, closures or caps are stored.
Those poisonous or toxic materials that are necessary are stored in a separate area of the plant in prominently and distinctly labeled containers. Provided that, this does not preclude the convenient availability of detergents or sanitizers to areas where containers, utensils and equipment are washed and sanitized.
Only insecticides and rodenticides approved by the Regulatory Agency and/or registered with the EPA shall be used for insect and rodent control. Such insecticides and rodenticides shall be used only in accordance with the manufacturer's label directions and shall be prevented from contaminating milk, containers, utensils and equipment.
In the case of separating non-Grade "A" and Grade "A" products, a water rinse after processing non-Grade "A" and prior to Grade "A" is adequate separation, provided both are processed as Grade "A", and raw and pasteurized products are kept physically separated.
Grade "A" raw milk or milk products and non-Grade "A" raw products, dairy or non-dairy, shall be separated by one valve.
Grade "A" pasteurized milk or milk products and non-Grade "A" pasteurized products, dairy or non-dairy, shall be separated by one valve.
Except during the actual flushing of raw product lines and vessels with water, there shall be a sufficient separation between water piping and unpasteurized dairy products, or lines used to conduct unpasteurized dairy products, to prevent the accidental addition of water.
During processing, pipelines and equipment used to contain or conduct milk and milk products shall be effectively separated from tanks or circuits containing cleaning and/or sanitizing solutions. This can be accomplished by:
Physically disconnecting all connection points between tanks or circuits containing cleaning and/or sanitizing solutions from pipelines and equipment used to contain or conduct milk or milk products; or,
Separation of all connection points between such circuits by at least two automatically controlled valves with a drainable opening to the atmosphere between the valves, or by a single bodied double seat valve, with a drainable opening to the atmosphere between the seats, if:
(1) The opening to the atmosphere (vent) is equal to the largest pipeline feeding the valve(s).
(2) Both valves, or valve seats in the case of single bodied double seat valves, are position detectable and capable of providing an electronic signal when not properly seated in the blocked position.
(3) These valves, or valve seats in the case of single bodied double seat valves, are part of an automatic failsafe system that will prevent contamination of product with cleaning or sanitizing solutions. Automatic fail safe systems will be unique to each particular installation but are normally based on the premise that both blocking valve seats are properly seated in the blocked position before the mechanical cleaning system can be activated for the cleaning circuit containing this valve arrangement.
(4) The system does not have any manual overrides.
(5) Controls for the fail-safe system are secured as directed by the Regulatory Agency in order to prevent unauthorized changes.
(6) The vent is not cleaned until milk and milk products have been removed or isolated.
(7) Variations from the above specifications may be individually evaluated and found to also be acceptable if the level of protection is not compromised.
For Example: In low pressure, gravity drain applications where the product line is the same size or larger than the cleaning or sanitizing solution line; the vent may be the size of the solution line and the valves or valve seats need not be position detectable. All other criteria still apply. In order to accept this variation, the valve(s) must fail to the blocked position upon loss of air or power, and there must be no pumps capable of pushing milk, milk product, cleaning solutions, or sanitizing solutions into this valve arrangement.
NOTE: The valve arrangement(s) described in this Section shall not be used to separate raw products, dairy, non-dairy or water, from pasteurized milk or milk products.
Except as permitted in Item 16p., there shall be no physical connection between unpasteurized products, dairy, non-dairy, or water, and pasteurized milk or milk products. Pasteurized non-dairy products or water not completely separated from pasteurized dairy products, shall be pasteurized at times and temperatures which meet at least the minimum times and temperatures provided for in Definition X or in the case of water have undergone an equivalent process found acceptable by FDA and the Regulatory Agency.
This Section does not require separate raw and pasteurized mechanical cleaning systems.
Pasteurized re-circulation lines, divert lines, and leak detect lines connecting to the raw product constant level supply tank shall be designed so that there is an air gap between the termination of these pipelines and the raw product overflow level. This air gap must be equivalent to at least two (2) times the diameter of the largest of these pipelines. For purposes of this section an overflow is defined as the flood rim of the constant level supply tank or any unrestricted opening below the flood rim of the constant level supply tank which is large enough that it is at least equivalent to two (2) times the diameter of the largest of these pipelines.
All milk and milk products that have overflowed, leaked, been spilled or improperly handled are discarded. Milk and milk products drained from processing equipment at the end of a run, collected from a defoamer system and milk solids rinsed from equipment, containers or pipelines shall be repasteurized only if such milk and milk products are handled in a sanitary manner and maintained at 7°C (45°F) or less. When the handling and/or refrigeration of such milk and milk products are not in compliance with this requirement, they shall be discarded. Milk and milk products from damaged, punctured or otherwise contaminated containers or product from out of code containers shall not be repasteurized for Grade "A" use.
Means are provided to prevent contamination of milk containers, utensils and equipment by drippings, spillage and splash from overhead piping, platforms or mezzanines.
The processing of foods and/or drinks other than Grade "A" milk and milk products are performed to preclude the contamination of such milk and milk products.
In no case shall pasteurized milk or milk products be standardized with unpasteurized milk unless the standardized product is subsequently pasteurized.
Reconstituted or recombined milk and milk products shall be pasteurized after reconstitution or recombining of all ingredients.
Pasteurization shall be performed as defined in Section 1, Definition X of this Ordinance. Aseptic processing shall be performed in accordance with 21 CFR 113, 21 CFR 108 and the Administrative Procedures of Item 16p., C, D and E of this Section. (See Appendix L.)
Health officials unanimously agree upon the public health value of pasteurization. Long experience conclusively shows its value in the prevention of disease that may be transmitted through milk. Pasteurization is the only practical, commercial measure, which, if properly applied to all milk, will destroy all milkborne disease organisms. Examination of lactating animals and milk handlers, while desirable and of great value, can be done only at intervals and; therefore, it is possible for pathogenic bacteria to enter the milk for varying periods before the disease condition is discovered. Disease bacteria may also enter milk accidentally from other sources, such as flies, contaminated water, utensils, etc. It has been demonstrated that the time-temperature combinations specified by this Ordinance, if applied to every particle of milk, will devitalize all milkborne pathogens. Compilations of outbreaks of milkborne disease by the PHS/FDA, over many years, indicate that the risk of contracting disease from raw milk is approximately fifty (50) times as great as from milk that has been "pasteurized".
A note of caution is in order. Although pasteurization destroys the organisms, it does not destroy the toxins that may be formed in milk when certain staphylococci are present, as from udder infections, and when the milk is not properly refrigerated before pasteurization. Such toxins may cause severe illness. Aseptic processing has also been conclusively demonstrated to be effective in preventing outbreaks from milkborne pathogens.
Numerous studies and observations clearly prove that the food value of milk is not significantly impaired by pasteurization.
The pasteurization portion of this Item is deemed to be satisfied when:
Every particle of milk or milk product is heated in properly designed and operated equipment to one of the temperatures specified in the following table and held continuously at or above that temperature for at least the time specified:
| Temperature | Time |
|---|---|
| 63°C (145°F) * | 30 minutes |
| 72°C (161°F) * | 15 seconds |
| 89°C (191°F) | 1.0 second |
| 90°C (194°F) | 0.5 seconds |
| 94°C (201°F) | 0.1 seconds |
| 96°C (204°F) | 0.05 seconds |
| 100°C (212°F) | 0.01 seconds |
*If the fat content of the milk product is 10 percent (10%) or more, or if it contains added sweeteners, the specified temperature shall be increased by 3°C (5°F).
Provided, that eggnog shall be heated to at least the following temperature and time specifications:
| 69°C (155°F) | 30 minutes |
| 80°C (175°F) | 25 seconds |
| 83°C (180°F) | 15 seconds |
Provided further, that nothing shall be construed as barring any other pasteurization process, which has been recognized by FDA to be equally efficient and which is approved by the Regulatory Agency.
The design and operation of pasteurization equipment and all appurtenances thereto shall comply with the applicable specifications and operational procedures of Subitems (A), (B), (D) and (E).
All indicating and recording thermometers used in connection with the batch pasteurization of milk or milk products shall comply with the applicable specifications set forth in Appendix H. Specifications for test thermometers and other test equipment appear in Appendix I.
Unless the temperature-control instruments and devices used on pasteurization equipment are accurate within known limits, there can be no assurance that the proper pasteurization temperature is being applied. Pasteurization must be performed in equipment which is properly designed and operated and which insures that every particle of milk or milk products will be held continuously at the proper temperature for the specified period of time.
Recording thermometers are the only known means for furnishing the Regulatory Agency with a record of the time and temperature of pasteurization. Experience has shown that recording thermometers, due to their mechanical complexity, are not entirely reliable. Therefore, mercury indicating thermometers or equivalent, which are much more reliable, are needed to provide a check on the recording thermometer and assurance that proper temperatures are being applied.
The recording thermometer shows the temperature of the milk immediately surrounding its bulb, but cannot indicate the temperature of the milk in other portions of the holder. Similarly, it shows the holding time in manual-discharge vats, but not in automatic-discharge systems. The pasteurizer must; therefore, be so designed and so operated and, where necessary, provided with such automatic controls, as to assure that every portion of the milk will be subjected to the proper temperature for the required length of time.
Unless the outlet valve and connections to the vats are properly designed and operated, cold pockets of milk may be held in the outlet valve or pipeline and raw or incompletely pasteurized milk may leak into the outlet line during the filling, heating or holding period.
Tests have shown that when foam is present on milk in vats or pockets during pasteurization, the temperature of the foam may be well below the pasteurization temperature. In such cases, pathogenic organisms that may be in the foam will not be killed. Experience indicates that some foam is present at some time in all vats, particularly at certain seasons. Furthermore, in filling vats, milk frequently is splashed on the surfaces and fixtures above the milk level, as well as on the underside of the vat cover. Droplets of this splash may drop back into the body of the milk, and since they may not have been at pasteurization temperature for the required time, they may contain pathogenic organisms. Heating the air above the milk, above pasteurization temperature, remedies these conditions. When air heating is not provided, its need may frequently be demonstrated by swabbing milk from the upper vat walls and from the underside of the cover, at the end of the holding period, and running phosphatase tests on the swab samples.
Many plant operators have reported that the use of airspace heaters, especially with partly filled vats with un-insulated lids, makes it easier to maintain the milk at a uniform and sufficiently high temperature. It also helps to prevent the growth of thermophilic organisms and promotes easier cleaning.
Obviously, if the design and construction of pasteurization vats and pocket covers do not prevent leakage, condensation and the entrance of water and dust, the milk may become contaminated with material containing disease bacteria. Keeping the covers closed during operation will decrease the chance of contaminants such as dust, insects, drip and splash from entering the milk.
This Item is deemed to be satisfied when:
TIME AND TEMPERATURE CONTROLS FOR BATCH PASTEURIZERS
Temperature Difference: The pasteurizer shall be so designed that the simultaneous temperature difference between the milk or milk product, at the center of the coldest milk or milk product in the vat, will not exceed 0.5°C (1°F) at any time during the holding period.
The vat shall be provided with adequate agitation, operating throughout the holding period. No batch of milk or milk product shall be pasteurized unless it covers a sufficient area of the agitator to insure adequate agitation.
Location and Required Readings of Indicating and Recording Thermometers: Each batch pasteurizer shall be equipped with both an indicating and a recording thermometer.
The thermometers shall not read less than the required pasteurization temperature throughout the required holding period. The plant operator shall check the temperature shown by the recording thermometer against the temperature shown by the indicating thermometer at the start of the holding period. This comparison shall be noted on the recording thermometer chart. The recording thermometer shall not read higher than the indicating thermometer. No batch of milk or milk products shall be pasteurized unless it is sufficient to cover the bulbs of both the indicating and the recording thermometer.
Assurance of Minimum Holding Periods: Batch pasteurizers shall be so operated that every particle of milk or milk product will be held at not less than the minimum pasteurization temperature continuously for at least thirty (30) minutes. When milk or milk products are raised to pasteurization temperature in the vat, and cooling is begun in the vat simultaneously with or before the opening of the outlet valve, the recording chart shall show at least thirty (30) minutes, at not less than minimum pasteurization temperature. When milk or milk products are preheated to pasteurization temperature before entering the vat, the recording chart shall show a holding period of at least thirty (30) minutes, at not less than the minimum pasteurization temperature plus the time of filling from the level of the recording thermometer bulb. When cooling is begun in the holder, after opening the outlet valve, or is done entirely outside the holder, the recording chart shall show at least thirty (30) minutes at not less than the minimum pasteurization temperature plus the time of emptying to the level of the recording thermometer bulb.
When the recording time interval on the recording chart at the pasteurization temperature includes filling and/or emptying time, such intervals shall be indicated on the recording chart, by the operator, by removing the recording thermometer bulb from the milk for a sufficient time to depress the pen; or by turning cold water into the vat jacket at the end of the holding period; or by inscribing the holding time on the recording chart. The filling time and the emptying time for each holder, so operated, shall be determined by the Regulatory Agency, initially and after any change which may affect these times.
No milk shall be added to the holder after the start of the holding period.
AIRSPACE HEATING
Means shall be provided and used in batch pasteurizers to keep the atmosphere above the milk and milk products at a temperature not less than 3°C (5°F) higher than the minimum required temperature of pasteurization, during the holding period. (See Appendix H.)
Each batch pasteurizer shall be equipped with an airspace thermometer. The surface of the milk or milk product shall be at least 25 millimeters (1 inch) below the bottom of the thermometer bulb when the vat is in operation.
The temperature shown by the airspace thermometer shall be recorded on the recording thermometer chart at the start of the holding period and at the end of the holding period, at a given time or reference point as indicated on the recording chart.
INLET AND OUTLET VALVES AND CONNECTIONS
The following definitions shall apply to inlet and outlet valves and connections:
"Valve Stop" shall mean a guide which permits turning the valve plug to, but not beyond, the fully closed position.
"The Fully Open Position" shall mean that position of the valve seat that permits the maximum flow into or out of the pasteurizer.
"The Closed Position" shall mean any position of the valve seat that stops the flow of milk into or out of the pasteurizer.
"The Fully Closed Position" shall mean that closed position of the valve seat which requires the maximum movement of the valve to reach the fully open position.
"The Just-Closed Position" shall mean that closed position of a plug-type valve in which the flow into or out of the holder is barely stopped, or any position within 2 millimeters (0.078 inches) thereof as measured along the maximum circumference of the valve seat.
"Leakage" shall mean the entrance of unpasteurized milk into a batch pasteurizer during the holding or emptying period, or the entrance of unpasteurized milk into any pasteurized milk line at any time.
"Leak-Protector Valve" shall mean a valve provided with a leak-diverting device, which, when the valve is in any closed position, will prevent leakage of milk past the valve.
"Close-Coupled valve" shall mean a valve, the seat of which is either flush with the inner wall of the pasteurizer or so closely coupled that no milk in the valve is more than 0.5°C (1°F) colder than the milk at the center of the pasteurizer at any time during the holding period.
A close-coupled valve which is not truly flush, shall be considered as satisfying this requirement when:
(1) The vat outlet is so flared that the smallest diameter of the large end of the flare is not less than the diameter of the outlet line, plus the depth of the flare; and
(2) The greatest distance from the valve seat to the small end of the flare is not greater than the diameter of the outlet line; and
(3) In the case of batch pasteurizers, the outlet and the agitator are so placed as to insure that milk currents will be swept into the outlet.
DESIGN AND INSTALLATION OF VALVES AND CONNECTIONS
All valves and connections shall comply with the following requirements:
Valves and pipeline connections shall meet the requirements of Item 10p.
All pipelines and fittings shall be so constructed and so located that leakage will not occur.
To prevent clogging, and to promote drainage, all leak-protection grooves in plug type outlet valves shall be at least 5 millimeters (0.187 inches wide) and at least 2.3 millimeters (0.094 inches) deep at the center. Mating grooves shall provide these dimensions throughout their combined length, whenever the valve is in, or approximately in, the fully closed position. All single leak grooves, and all mating leak grooves when mated, shall extend throughout the entire depth of the seat, so as to divert leakage occurring at all points throughout the depth of the seat and so as to prevent air binding. Washers or other parts shall not obstruct leak-protector grooves.
A stop shall be provided on all plug-type outlet valves in order to guide the operator in closing the valve so that un-pasteurized milk may not inadvertently be permitted to enter the outlet line. The stop shall be so designed that the plug will be irreversible when the plug is provided with any grooves or their equivalent, unless duplicate, diametrically opposite grooves are also provided. Stops shall be so designed that the operator cannot turn the valve beyond the stop position, either by raising the plug or by any other means.
Outlet valves, in addition to the requirements listed above, shall be so designed as to prevent the accumulation of un-pasteurized milk in the milk passages of the valve when the valve is in any closed position.
All outlets from vat pasteurizers shall be equipped with close-coupled leak-protector valves or be otherwise similarly protected during filling, holding and emptying periods.
All leak-protector valves outlet valves shall be installed in the proper position to insure the function of the leak-protector groves and the drainage of the leak-detector valve.
All outlet valves shall be kept fully closed during filling, heating, and holding periods.
Close-coupled vat pasteurizer outlet valve bodies and plugs shall be made of stainless steel or of other materials that have heat transfer properties at least equal to stainless steel.
All inlet pipelines are disconnected during the holding and emptying periods.
RECORDING CHARTS
All recording thermometer charts shall comply with all the applicable requirements of Item 16p.(E),1.a.
(See Public Health Reason under Item 16p. and 16p.(A).)
This Item is deemed to be satisfied when:
INDICATING THERMOMETER AND RECORDER/CONTROLLER INSTRUMENTS
All indicating thermometers and recorder/controller instruments and devices used in connection with the HTST, continuous-flow pasteurization of milk or milk products shall comply with the applicable specifications set forth in Appendix H.
AUTOMATIC MILK CONTROLLER
Each HTST, continuous-flow pasteurization system shall be equipped with an automatic milk-flow control of the diversion type, which complies with the following definition, specifications and performance requirements:
Automatic Milk-Flow Controls: The term "automatic milk-flow controls" shall mean those safety devices which control the flow of milk in relation to the temperature of the milk, or heating medium and/or pressure, vacuum or other auxiliary equipment. Milk-flow controls shall not be considered as part of the temperature control equipment. Milk-flow controls shall be of the flow-diversion type, which automatically cause the diversion of the milk in response to a sub-legal pasteurization temperature. At sub-legal temperatures, flow-diversion devices (FDD) return the milk to the raw milk side of the heating system continuously until legal pasteurization temperatures are obtained, at which time, the device restores forward flow through the pasteurizer.
FDD's: All FDD's used in continuous pasteurizers shall comply with the following or equally satisfactory specifications:
(1) The forward flow of milk below the minimum pasteurization temperature shall be prevented by requiring the timing pump to be de-energized when the milk is below the pasteurization temperature and the valve is not in the fully diverted position; or by any other equally satisfactory means.
(2) When a packing gland is used to prevent leakage around the actuating stem, it shall be impossible to tighten the stem-packing nut to such an extent as to prevent the valve from assuming the fully diverted position.
(3) A leak-escape shall be installed on the forward-flow side of the valve seat. However, when backpressure is exerted on the forward-flow side of the valve seat, while the milk-flow is being diverted, the leak-escape should lie between two valve seats or between two portions of the same seat, one upstream and the other downstream from the leak-escape. The leak-escape shall be designed and installed to discharge all leakage to the outside, or to the constant-level tank through a line separate from the diversion line. Provided, that when leakage is discharged to the constant-level tank, a sight glass shall be installed in the leak-escape line to provide a visual means of leak detection.
(4) The closure of the forward-flow seat shall be sufficiently tight so that leakage past it will not exceed the capacity of the leak-escape device, as evidenced when the forward-flow line is disconnected; and, in order that proper seating may not be disturbed, the length of the connecting rod shall not be adjustable by the user.
(5) The FDD shall be so designed and installed that failure of the primary motivating power shall automatically divert the flow of milk.
(6) The FDD shall be located downstream from the holder. The flow-control sensor shall be located in the milk line not more than 46 centimeters (18 inches) upstream from the FDD.
(7) In the case of higher-heat-shorter-time (HHST) pasteurizing systems utilizing temperatures of 89°C (191°F) and above; and holding times of one (1) second or less, the FDD may be located downstream from the regenerator and/or cooler section. Provided, that when the FDD is located downstream from the regenerator and/or cooler section, the FDD shall be automatically prevented from assuming the forward-flow position until all product-contact surfaces between the holding tube and FDD have been held at or above the required pasteurization temperature continuously and simultaneously for at least the required pasteurization time as defined in Definition X of this Ordinance.
(8) The pipeline from the diversion port of the FDD shall be self-draining and shall be free of restrictions or valves; unless such restrictions are noticeable and valves are so designed that stoppage of the diversion line cannot occur.
(9) When it is used, the pipeline from the leak-detector port of the FDD shall be self-draining and shall be free of restrictions or valves.
(10) For the timing pump, a one (1) second maximum "off" time delay is allowed to maintain the flow-promoting device in the "on" position through the travel time of the FDD.
(11) If the area between the divert and detect valve seats is not self-draining when the FDD is in the diverted position, a delay of at least one (1) second and not more than five (5) seconds is required between the movement of the divert and detect valves when the FDD assumes the forward flow position. Except that, the delay may be longer than five (5) seconds if: the timing system is a magnetic flow meter based timing system; or if the holding time in diverted flow through an unrestricted divert valve line is longer than the required pasteurization time as specified in Definition X of this Ordinance; and except that, no time delay is required in pasteurization systems in which the FDD is located down stream from the pasteurized regenerator and in which all forward flow product-contact surfaces of the FDD are sanitized, or sterilized during the normal start-up process.
Milk-Flow Controller Instrumentation: The following requirements shall be met with respect to the instrumentation of the milk-flow controller:
(1) The thermal-limit-controller shall be set and sealed so that forward flow of product cannot start unless the temperature at the controller sensor is above the required pasteurization temperature as defined in Definition X of this Ordinance for the milk or milk product and the process used, nor continue during descending temperatures when the temperature is below the required pasteurization temperature. The seal shall be applied by the Regulatory Agency after testing, and shall not be removed without immediately notifying the Regulatory Agency. The system shall be so designed that no milk can be bypassed around the controller sensor that shall not be removed from its proper position during the pasteurization process. The cut-in and cut-out milk temperatures, as shown by the indicating thermometer, shall be determined at the beginning of each day's operation and entered upon the recorder chart daily by the plant operator.
(2) In the case of HHST pasteurization systems, utilizing the temperatures of 89°C (191°F) and above, and holding times of one (1) second or less, with the FDD located downstream from the regenerator and/or cooler section, additional temperature controllers and timers shall be inter-wired with the thermal-limit-controller, and the control system shall be set and sealed so that forward flow of product cannot start until all product-contact surfaces between the holding tube and FDD have been held at or above the required pasteurization temperature, continuously and simultaneously for at least the required pasteurization time as defined in Definition X of this Ordinance. The control system shall also be set and sealed so that forward flow cannot continue when the temperature of the product in the holding tube is below the required pasteurization temperature. The seal shall be applied by the Regulatory Agency after the equipment has been tested, and shall not be removed without immediately notifying the Regulatory Agency. The system shall be so designed that no product can be bypassed around the control sensors, which shall not be removed from their proper position during the pasteurization process. For these HHST systems, daily measurement by the operator of the cut-in and cut-out temperatures is not required.
(3) Manual switches for the control of pumps, homogenizers or other devices which produce flow through the holder, shall be wired so that the circuit is completed only when milk is above the required pasteurization temperature as defined in Definition X of this Ordinance for the milk or milk product and the process used, or when the diversion device is in the fully-diverted position.
Holding Tube:
(1) Holding tubes shall be designed to provide for the holding of every particle of milk or milk product for at least the time required in Definition X of this Ordinance for the milk or milk product and the process used.
(2) The holding tube shall be so designed that the simultaneous temperature difference between the hottest and coldest milk, in any cross section of flow, at any time during the holding period, will not be greater than 0.5°C (1°F). This requirement may be assumed to have been satisfied, without testing, in tubular holders of 17.8 centimeters (7 inches) or smaller diameter that are free of any fittings through which the milk may not be thoroughly swept.
(3) No device shall be permitted for short-circuiting a portion of the holding tube to compensate for changes in rate of milk-flow. Holding tubes shall be installed so that sections of pipe cannot be left out, resulting in a shortened holding time.
(4) The holding tube shall be arranged to have a continuously upward slope in the direction of flow of not less than 2.1 centimeters per meter (0.25 inches per foot).
(5) Supports for holding tubes shall be provided to maintain all parts of the holding tubes in a fixed position, free from any lateral or vertical movement.
(6) The holding tube shall be so designed that no portion between the inlet and the recorder-controller temperature sensor is heated.
The following items apply to HHST systems:
(7) The holding time for HHST systems must be determined from the pumping rate rather than by the salt conductivity test, because of the short holding tube. The holding tube length must be such that the fastest flowing particle, of any product, will not traverse the holding tube in less than the required holding time. Since laminar flow, the fastest flowing particle travels twice as fast as the average flowing particle, can occur in the holding tube during pasteurization of high-viscosity products, holding tube lengths are calculated as twice the length required to hold the average flow for the time standard.
(8) With the direct steam heating processes, the holding time is reduced because the product volume increases as the steam condenses to water during heating in the injector. This surplus water is evaporated as the pasteurized product is cooled in the vacuum chamber. For example, with a 66°C (120°F) increase by steam injection, which is probably the maximum temperature rise that will be used, a volume increase of twelve percent (12%) will occur in the holding tube. The measurement of the average flow rate, at the discharge of the pasteurizer, does not reflect this volume increase in the holding tube. However, this volume increase, i.e., holding time decrease, must be considered in the calculations.
(9) For those HHST systems capable of operating with less that 518 kPa (75 psig) pressure in the holding tube, a pressure limit indicator/pressure switch must be interwired so that the FDD will move to the divert position if the product pressure falls below a prescribed value. For operating temperatures between 89°C (191°F) and 100°C (212°F) the instrument must be set at 69 kPa (10 psi). To prevent vaporization in the holding tube (which may substantially reduce residence times) HHST systems operating above 100°C (212°F), the instrument must be set at 69 kPa (10 psi) above the boiling pressure of the product, at its maximum temperature in the holding tube.
(10) With the steam injection process, a differential pressure limit indicator across the injector is needed to ensure adequate isolation of the injection chamber. The instrument must have a differential pressure switch so that the FDD will move to the divert position if the pressure drop across the injector falls below 69 kPa (10 psi).
Indicating and Recording Thermometers:
(1) An indicating thermometer shall be located as near as practicable to the temperature sensor of the recorder/controller, but may be located a short distance upstream from the latter where milk between the two thermometers does not differ significantly in temperature.
(2) The temperature shown by the recorder/controller shall be checked daily by the plant operator against the temperature shown by the indicating thermometer. Readings shall be recorded on the chart. The recorder/controller shall be adjusted to read no higher than the indicating thermometer.
(3) The recorder/controller charts shall comply with the applicable provisions of Item 16p.(E),1.a.
Flow-Promoting Devices:
(1) The pump or pumps and other equipment which may produce flow through the holding tube shall be located upstream from the holding tube, provided that pumps and other flow-promoting devices may be located downstream from the holding tube, if means are provided to eliminate negative pressure between the holding tube and the inlet to such equipment. When vacuum equipment is located downstream from the holding tube, an effective vacuum breaker, plus an automatic means of preventing a negative pressure in the line between the FDD and the vacuum chamber, shall be acceptable.
(2) The speed of pumps or other flow-promoting devices, governing the rate of flow through the holding tube, shall be so controlled as to insure the holding of every particle of milk for at least the time required as defined in Definition X of this Ordinance for the milk or milk product and the process used. In all cases, the motor shall be connected to the timing pump by means of a common drive shaft, or by means of gears, pulleys, or a variable-speed drive, with the gear box, the pulley box or the setting of the variable speed protected in such a manner that the holding time cannot be shortened without detection by the Regulatory Agency. This shall be accomplished by the application of a suitable seal(s) after being tested by the Regulatory Agency and such seal shall not be broken without immediately notifying the Regulatory Agency. This provision shall also apply to all homogenizers used as timing pumps. Variable speed drives, used in connection with the timing pump, shall be so constructed that wearing or stretching of the belt results in a slowdown, rather than a speedup, of the pump.
The metering or timing pump shall be of the positive displacement type or shall comply with the specifications for magnetic flow meter based timing systems as outlined in Appendix H. Timing pumps and homogenizers, when used as a timing pump, shall not have by-pass lines connected from their outlet pipelines to their inlet pipelines during processing if an additional flow-promoting or vacuum producing device is located within the system. When a homogenizer is used in conjunction with a timing pump it shall be either:
Of larger capacity than the timing pump: In which case, an unrestricted, open, recirculation line shall be used to connect the outlet pipeline from the homogenizer to its inlet line. The recirculation line must be of at least the same or larger diameter than the inlet pipeline feeding product to the homogenizer. A check valve, allowing flow from the outlet line to the inlet line, may be used in the recirculating line, provided it is of the type which provides a cross-sectional area at least as large as the recirculating line.
Of smaller capacity than the timing pump: In which case, a relief line and valve shall be used. Such relief line shall be located after the timing pump and before the inlet to the homogenizer and shall return product to the constant-level tank or to the outlet of the constant-level tank, upstream of any booster pump or other flow-promoting device.
For those systems that do not homogenize all products and wish to utilize a by-pass line to by-pass the homogenizer while processing such product; the by-pass line must be connected with valves that are so designed that both lines cannot be open at the same time. This may be accomplished with three (3)-way plug valves with properly designed and operating pins or other automatic, fail-safe valves that accomplish the same objective.
(3) The holding time shall be taken to mean the flow time of the fastest particle of milk, at or above the required pasteurization temperature as defined in Definition X of this Ordinance for the milk or milk product and the process used, throughout the holding tube section; i.e., that portion of the system that is outside of the influence of the heating medium, slopes continuously upward in the downstream direction and is located upstream from the FDD. Tests for the holding time shall be made when all equipment and devices are operated and adjusted to provide for maximum flow. When a homogenizer is located upstream from the holding tube, the holding time shall be determined with the homogenizer in operation with no pressure on the homogenizer valves.
For those systems which do not homogenize all products and utilize by-pass lines as outlined in (i) above, the holding time shall be tested in both flow patterns and the fastest time used. The holding time shall be tested during both forward and diverted flow. If it is necessary to lengthen the holding time during diverted flow, an identifiable restriction may be placed in the vertical portion of the diversion pipeline. When vacuum equipment is located downstream from the holding tube, the holding time shall be tested with the timing pump operating at maximum flow and the vacuum equipment adjusted to provide for the maximum vacuum.
The holding time shall be tested in both forward and diverted flow by the Regulatory Agency initially; semiannually thereafter; after any alteration or replacement that may affect the holding time; and whenever the seal of the speed setting has been broken.
Heating by Direct Addition of Steam: Steam injection is an inherently unstable process; accordingly, when steam is injected into a fluid, condensation of the steam may not be completed inside the injector unless the proper design criteria are used. Lack of complete condensation inside the injector would cause temperature variations in the holding tube that could lead to some product particles being processed below pasteurization temperature. When culinary steam is injected directly into milk or milk products, as the means of terminal heating to achieve pasteurization temperature, the steam injector shall be designed, installed and operated to comply with the following or equally satisfactory specifications:
(1) The product and steam flows must be isolated from pressure fluctuations inside the injection chamber. One (1) method of isolation is to insert supplementary orifices on the product inlet and the heated product outlet of each injector. The two (2) supplementary orifices must be sized for at least a 69 kPa (10 psi) product pressure drop across the injector during a simulation of normal operations. Excessive vibrations, pressure fluctuations or erratic noise levels indicate an unstable steam injection system and a need to check the isolation of the injection chamber.
(2) The process should be as free as possible of non-condensable gases that may evolve from the product or be carried in the steam supply. Any two-phase flow caused by the non-condensable gases would displace the product in the holding tube, resulting in reduced residence times. In addition, these gases in the steam supply may also markedly alter the condensation mechanism at the point of injection. Accordingly, the steam boiler shall be supplied with a de-aerator. The de-aerator will aid in keeping the product in the holding tube as free as possible of non-condensable gases.
Prevention of Product Adulteration with Added Water:
(1) When culinary steam is introduced directly into the milk or milk product downstream from the FDD, means shall be provided to preclude the addition of steam to the product, unless the FDD is in the forward-flow position. This provision may be satisfied by the use of an automatic steam control valve with a temperature sensor located downstream from the steam inlet, or by the use of an automatic solenoid valve installed in the steam line and so wired through the FDD controls, so that steam cannot flow unless the FDD is in the forward-flow position.
(2) When culinary steam is introduced directly into the milk or milk product, automatic means, i.e., stand-alone and/or PLC-based ratio control system, shall be provided to maintain a proper temperature differential between incoming and outgoing milk to preclude dilution with water.
(3) Where a water feed line is connected to a vacuum condenser and the vacuum condenser is not separated from the vacuum chamber by a physical barrier, means shall be provided to preclude the backup and overflow of water from the vacuum condenser to the vacuum chamber. This provision may be satisfied by the use of a safety shutoff valve, located on the water feed line to the vacuum condenser, which is automatically actuated by a control which will shut off the in-flowing water, if for example, the condensate pump stops and the water level rises above a predetermined point in the vacuum condenser. This valve may be actuated by water, air or electricity and shall be so designed that failure of the primary motivating power will automatically stop the flow of water into the vacuum condenser.
Aseptically processed milk and milk products are being packaged in hermetically sealed containers and stored for long periods of time under non-refrigerated conditions. These conditions are favorable to the growth of many types of bacteria, including pathogenic, toxin producing and spoilage organisms. Because of this, every precaution must be taken to ensure that the chosen heat process, for the particular milk or milk product, destroys all viable organisms and their spores. The subsequent handling, packaging and storage processes do not provide an opportunity for recontamination of the product. The selected process must conform to the acceptable requirements for low acid canned foods.
This Item is deemed to be satisfied when:
The design and operation of aseptic processing systems comply with the applicable specifications and operational procedures of Item 16p. sub-items (C), (D) and (E). Provided, that nothing shall be construed as barring any other aseptic processing system which have been recognized by FDA to be equally effective and which is approved by the Regulatory Agency.
INDICATING THERMOMETERS AND RECORDER/CONTROLLER INSTRUMENTS
All indicating thermometers, recorder/controller instruments and devices, used in connection with aseptic processing systems, used for the aseptic processing of milk or milk products shall comply with the applicable specifications set forth in Appendix H.
ASEPTIC PROCESSING EQUIPMENT
Temperature Indicating Device: Each aseptic processing system shall be equipped with at least one (1) mercury-in-glass thermometer or an equivalent temperature-indicating device.
Temperature Recorder/Controller: An accurate temperature recorder/controller shall be installed in the product at the holding tube outlet and before the inlet to the cooler or regenerator. The following requirements shall be met with respect to the instrumentation of the temperature recorder/controller:
(1) The temperature recorder/controller shall be set and sealed so that during product processing the forward flow of product cannot start unless the temperature at the controller sensor is above the required temperature for the product and the process used, nor continue during descending temperatures when the temperature is below the required temperature.
The seal shall be applied by the Regulatory Agency after testing and shall not be removed without immediately notifying the Regulatory Agency. The system shall be so designed that no product can be bypassed around the controller sensor, which shall not be removed from its proper position during the processing of aseptic milk and milk products.
(2) Additional temperature-controllers and timers shall be interwired with the thermal-limit controller, and the control system shall be set and sealed so that forward flow of product cannot start until all product-contact surfaces between the holding tube and FDD have been held at or above the required sterilization temperature, continuously and simultaneously for at least the required sterilization time. The control system shall also be set and sealed so that forward flow cannot continue when the temperature of the product in the holding tube is below the required temperature. The seal shall be applied by the Regulatory Agency after being tested and shall not be removed without immediately notifying the Regulatory Agency. The system shall be so designed that no product can be bypassed around the control sensors, which shall not be removed from their proper position during the processing of aseptic milk and milk products.
(3) Manual switches for the control of pumps, homogenizers or other devices that produce flow through the holding tube, shall be wired so that the circuit is completed only when the milk is above the required temperature for the product and the process used, or when the FDD is in the fully diverted position.
Timing Pump:
(1) A timing pump shall be located upstream from the holding tube and shall be operated to maintain the required rate of product flow. The motor shall be connected to the timing pump by means of a common drive shaft, or by means of gears, pulleys or a variable-speed drive, with the gear box, the pulley box or the setting of the variable speed protected in such a manner that the hold time cannot be shortened without detection by the Regulatory Agency. This shall be accomplished by the application of a suitable seal(s) after being tested by the Regulatory Agency and such seal shall not be broken without immediately notifying the Regulatory Agency. This provision shall apply to all homogenizers used as timing pumps. Variable speed drives, used in connection with the timing pump, shall be so constructed that wearing or stretching of the belt results in a slowdown, rather than a speedup, of the pump. The metering or timing pump shall be of the positive displacement type or shall comply with the specifications for magnetic flow meter based timing systems.
(2) The holding time shall be taken to mean the flow time of the fastest particle of product throughout the holding tube section, i.e., that portion of the system that is outside of the influence of the heating medium; and slopes continuously upward in the down-stream direction; and is located upstream from the FDD.
Product Holding Tube:
(1) The product holding tube shall be designed to give continuous holding of every particle of product for at least the minimum holding time specified in the scheduled process. The holding tube shall be designed, so that no portion of the tube between the product inlet and the product outlet can be heated. In addition, it must be sloped upward at least 2.1 centimeters per meter (0.25 inches per foot). Supports for holding tubes shall be provided to maintain all parts of the holding tubes in a fixed position, free from any lateral or vertical movement.
(2) No device shall be permitted for short-circuiting a portion of the holding tube to compensate for changes in rate of product flow. Holding tubes shall be installed so that sections of pipe cannot be left out, resulting in a shortened holding time. The holding time for the processes must be determined from the pumping rate, rather than by the salt conductivity test.
(3) The holding tube length must be such that the fastest flowing particle of any product will not traverse the holding tube in less than the required holding time.
NOTE: With the direct addition of steam, the holding time is reduced because the product volume increases as the steam condenses to water during heating. This surplus water is evaporated as the aseptically processed product is cooled in the vacuum chamber. For example, with a 66°C (120°F) increase by steam injection, which is probably the maximum temperature rise that will be used, a volume increase of twelve percent (12%) will occur in the holding tube. The measurement of the average flow rate at the discharge of the aseptic processor does not reflect this volume increase in the holding tube. However, this volume increase, i.e., holding time decrease, must be considered in the calculations.
(4) An aseptic processing system which can operate with product in forward flow mode, with less than 518 kPa (75 psig) pressure in the holding tube shall be equipped with a pressure limit indicator/pressure switch in the holding tube to assure that the heated product remains in the liquid phase. In systems that do not have a vacuum chamber between the holding tube and the aseptic product side of the regenerator, this can be established by verifying that the aseptic processing equipment cannot operate in forward flow with less than 518 kPa (75 psig) pressure on the aseptically processed side of the regenerator. (See Appendix I., Test 9). The pressure limit indicator/pressure switch must be interwired so that the FDD, product divert system, product divert valve or other acceptable control system will move to the divert position, if the product pressure falls below a prescribed value. The instrument must be set at a pressure 69 kPa (10 psi) above the boiling pressure of the product at its maximum temperature in the holding tube. If this pressure is too low, the resultant vaporization in the holding tube will substantially reduce residence times.
(5) With the steam injection process, a differential pressure limit indicator, across the injector, is needed to ensure adequate isolation of the injection chamber. The instrument must have a differential pressure switch so that the FDD will move to the divert position if the pressure drop across the injector falls below 69 kPa (10 psi).
Heating by Direct Addition of Steam: Steam injection is an inherently unstable process; accordingly, when steam is injected into a fluid, condensation of the steam may not be completed inside the injector unless the proper design criteria are used. Lack of complete condensation inside the injector would cause temperature variations in the holding tube, which could lead to some product particles being processed below filed process temperature. When culinary steam is injected directly into milk or milk products, as the means of terminal heating to achieve aseptic processing temperature, the steam injector shall be designed, installed and operated to comply with the following or equally satisfactory specifications:
(1) The product and steam flows must be isolated from pressure fluctuations inside the injection chamber. One (1) method of isolation is to insert supplementary orifices on the product inlet and the heated product outlet of each injector. The two (2) supplementary orifices must be sized for at least a 69 kPa (10 psi) product pressure drop across the injector during a simulation of normal operations. Excessive vibrations, pressure fluctuations or erratic noise levels indicate an unstable steam injection system and a need to check the isolation of the injection chamber.
(2) The process should be as free as possible of non-condensable gases that may evolve from the product or be carried in the steam supply. Any two (2) phase flow, caused by the non-condensable gases, would displace the product in the holding tube, resulting in reduced residence times. In addition, these gases in the steam supply may also markedly alter the condensation mechanism at the point of injection. Accordingly, the steam boiler shall be supplied with a deaerator. The deaerator will aid in keeping the product in the holding tube as free as possible of non-condensable gases.
Prevention of Product Adulteration with Added Water:
(1) When culinary steam is introduced directly into the milk or milk product, automatic means, i.e., stand-alone and/or PLC-based ratio control system, shall be provided to maintain a proper temperature differential between incoming and outgoing milk to preclude dilution with water.
(2) Where a water feed line is connected to a vacuum condenser and the vacuum condenser is not separated from the vacuum chamber by a physical barrier, means shall be provided to preclude the back-up and overflow of water from the vacuum condenser into the vacuum chamber. This provision may be satisfied by the use of a safety shutoff valve, located on the water feed line to the vacuum condenser that is automatically actuated by a control that shuts off the in-flowing water. This valve may be actuated by water, air or electricity and shall be so designed that failure of the primary motivating power will automatically stop the flow of water into the vacuum condenser.
Flow-Diversion Device: All FDD's used in continuous aseptic process systems shall comply with Item 16p.(B).2.b. or equally satisfactory specifications.
To prevent contamination of the pasteurized milk in regenerators, the raw milk must always be under less pressure than the pasteurized milk or the heat-transfer medium. In the case of milk-to-milk regenerators, this requirement is necessary to prevent contamination of the pasteurized product by the raw milk if flaws should develop in the metal or joints separating the raw and pasteurized milk.
This Item is deemed satisfied when:
Pasteurizers and aseptic processing systems employing milk-to-milk regenerative heating with both sides closed to the atmosphere shall comply with the following or equally satisfactory specifications:
Regenerators shall be constructed, installed and operated so that pasteurized or aseptic product in the regenerator will automatically be under greater pressure than raw milk in the regenerator at all times.
The pasteurized or aseptic product, between its outlet from the regenerator and the nearest point downstream open to the atmosphere, shall rise to a vertical elevation of 30.5 centimeters (12 inches) above the highest raw milk level, downstream from the constant-level tank, and shall be open to the atmosphere at this or a higher elevation.
The overflow of the top rim of the constant-level tank shall always be lower than the lowest milk level in the regenerator.
No pump or flow-promoting device which can affect the proper pressure relationships within the regenerator shall be located between the pasteurized or aseptic product outlet from the regenerator and the nearest downstream point open to the atmosphere.
No pump shall be located between the raw milk inlet to the regenerator and the constant-level tank, unless it is designed and installed to operate only when milk is flowing through the pasteurized or aseptic product side of the regenerator and when the pressure of the pasteurized or aseptic product is higher than the maximum pressure produced by the pump. This may be accomplished by wiring the booster pump so that it cannot operate unless:
The timing pump is in operation;
The FDD is in forward-flow position; and
The pasteurized or aseptic product pressure exceeds, by at least 6.9 kPa (1 psi), the maximum pressure developed by the booster pump. Pressure gauges shall be installed at the raw milk inlet to the regenerator and the pasteurized or aseptic product outlet of the regenerator or the outlet of the cooler. The accuracy of these required pressure gauges shall be checked, by the Regulatory Agency, on installation; quarterly thereafter; and following repair or adjustment.
The motor, casing and impeller of the booster pump shall be identified, and such records maintained as directed by the Regulatory Agency. All electric wiring interconnections should be in permanent conduit, except that rubber covered cable may be used for final connections, with no electrical connections to defeat the purpose of any provisions of this Ordinance.
All raw milk in the regenerator will drain freely back into the constant-level raw milk tank when the raw milk pump(s) are shut down and the raw milk outlet from the regenerator is disconnected.
When vacuum equipment is located downstream from the FDD, means shall be provided to prevent the lowering of the pasteurized or aseptic product level in the regenerator during periods of diverted flow or shutdown. An effective vacuum breaker, plus an automatic means of preventing a negative pressure, shall be installed in the line between the vacuum chamber and the pasteurized or aseptic product inlet to the regenerator.
In the case of HHST pasteurization systems utilizing the temperatures of 89°C (191°F) and above and holding times of one (1) second or less, with the FDD located downstream from the regenerator and/or cooler section, the requirement that the pasteurized product from the outlet of the regenerator or cooler shall rise to a vertical elevation of 30.5 centimeters (12 inches) above the highest raw product level downstream from the constant-level tank and shall be open to the atmosphere at this or a higher elevation, may be eliminated. Provided, that a differential pressure controller is used to monitor the highest pressure in the raw product side of the regenerator and the lowest pressure in the pasteurized side of the regenerator, and the controller is interlocked with the FDD and is set and sealed so that whenever improper pressures occur in the regenerator, forward flow of product is automatically prevented and will not start again until all product-contact surfaces between the holding tube and FDD have been held at or above the required pasteurization temperature, continuously and simultaneously for at least the required pasteurization time as defined in Definition X of this Ordinance.
In the case of aseptic processing systems used for producing aseptic milk and milk products, there shall be an accurate differential pressure recorder-controller installed on the regenerator. The scale divisions shall not exceed 13.8 kPa (2 psi) on the working scale of not more than 138 kPa (20 psi) per 2.54 centimeters (1 inch). The controller shall be tested for accuracy against a known accurate standard pressure indicator upon installation; at least once every three (3) months of operation thereafter; or more frequently if necessary, to ensure its accuracy. One (1) pressure sensor shall be installed at the aseptic product regenerator outlet and the other pressure sensor shall be installed at the raw product regenerator inlet.
When culinary steam is introduced directly into milk or milk products to achieve pasteurization or aseptic processing temperature, and vacuum equipment is located downstream from the holding tube, the requirement that a vacuum breaker be installed at the inlet to the pasteurized or aseptic side of the regenerator may be eliminated. Provided, that the differential pressure controller is installed and wired to control the FDD as described in Paragraph 9 of this Section.
When the differential pressure controller is installed and wired to control the FDD as described in Paragraph 9 of this Section, the raw product booster pump may be permitted to run at all times. Provided, that the timing pump is in operation.
Option 1. Milk-to-water-to-milk regenerators, with both the milk and the heat-transfer water in the raw milk section, closed to the atmosphere, shall comply with the following or equally satisfactory specifications:
Regenerators of this type shall be so designed, installed and operated that the heat-transfer-medium side of the regenerator, in the raw milk section, will automatically be under greater pressure than the raw milk side at all times.
The heat-transfer water shall be a safe water and the heat-transfer water shall be in a covered tank, which is open to the atmosphere at an elevation higher, by at least 30.5 centimeters (12 inches), than any raw milk level downstream from the constant-level tank. The heat-transfer water between its outlet from the regenerator and the nearest point downstream open to the atmosphere shall rise to a vertical elevation of at least 30.5 centimeters (12 inches) above any raw milk in the system and shall be open to the atmosphere at this or a higher elevation.
The heat-transfer water circuit shall be full of water at the beginning of the run and all loss of water from the circuit shall be automatically and immediately replenished whenever raw milk is present in the regenerator.
The overflow of the top rim of the constant-level tank shall always be lower than the lowest milk level in the raw milk section of the regenerator. The regenerator shall be designed and installed so that all raw milk shall drain freely back to the upstream supply tank when the raw milk pumps are shut down and the raw milk line is disconnected from the regenerator outlet.
No pump shall be located between the raw milk inlet to the regenerator and the constant-level tank, unless it is designed and installed to operate only when water is flowing through the heat-transfer section of the regenerator and when the pressure of the heat-transfer water is higher than the pressure of the raw milk. This may be accomplished by wiring the booster pump so that it cannot operate unless:
(1) The heat-transfer water pump is in operation; and
(2) The heat-transfer water pressure exceeds, by at least 6.9 kPa (1 psi), the raw milk pressure in the regenerator. A differential pressure-controller shall be installed at the raw milk inlet and the heat-transfer water outlet of the regenerator. The raw milk booster pump must be wired so that it cannot operate unless the differential pressure is met. The accuracy of the required differential pressure-controller shall be checked by the Regulatory Agency on installation; quarterly thereafter; and following repair or replacement.
Option 2. Milk-to-water-to-milk regenerators may also be constructed, installed and operated such that the pasteurized or aseptic product in the regenerator will be under greater pressure than the heat-transfer-medium in the pasteurized or aseptic product side of the regenerator:
A differential pressure controller shall be used to monitor pressures of the pasteurized product and the heat-transfer-medium.
In the case of aseptic processing systems, a differential pressure-recorder shall be used to monitor pressures of the aseptic product and the heat-transfer-medium.
In either case, one pressure sensor shall be installed at the pasteurized or aseptic product outlet of the regenerator and the other pressure sensor shall be installed at the heat-transfer-medium inlet of the pasteurized or aseptic product side of the regenerator. This controller or recorder-controller shall divert the FDD whenever the lowest pressure of pasteurized or aseptic product in the regenerator fails to exceed the highest pressure of heat-transfer-medium in the pasteurized or aseptic product side of the regenerator by at least 6.9 kPa (1 psi). Forward flow of product shall be automatically prevented until all product-contact surfaces between the holding tube and the FDD have been held at or above the required pasteurization or sterilization temperature continuously and simultaneously for at least the pasteurization or sterilization time.
The heat-transfer-medium pump shall be wired so that it cannot operate unless the timing pump is in operation.
NOTE: See Appendix H. for further discussion concerning methods of achieving the required pressure relationships within the regenerator.
PASTEURIZATION AND ASEPTIC PROCESSING RECORDS
All temperature and flow rate pasteurization recording charts or alternative records acceptable to FDA in place of charts shall be preserved for a period of three (3) months. Provided, that all records and recording charts for aseptic milk and milk product systems shall be retained for a period of three (3) years. The use of such charts shall not exceed the time limit for which they are designed. Overlapping of recorded data shall be a violation of this Item. The following information shall be entered on the charts or other records acceptable to FDA in place of charts as applicable:
Batch Pasteurizers:
(1) Date;
(2) Number or location of recording thermometer when more than one is used;
(3) A continuous record of the product temperature;
(4) Extent of holding period, including filling and emptying times when required;
(5) Reading of airspace thermometer, at the start of the holding period and at the end of the holding period, at a given time or reference point as indicated on the chart;
(6) Reading of indicating thermometer, at the start of the holding period, at a given time or reference point as indicated on the chart;
(7) Quarterly, the initials of the Regulatory Agency opposite the required readings of the indicating thermometer and airspace thermometer;
(8) Quarterly, the time accuracy of the recording thermometer, as determined by the Regulatory Agency;
(9) Amount and name of pasteurized milk or milk product represented by each batch or run on the chart;
(10) Record of unusual occurrences;
(11) Signature or initials of operator; and
(12) Name of milk plant.
HTST and HHST Pasteurizers:Recording thermometer charts shall contain all the information specified in Subitem a. above, except (4), (5) and reference to the airspace thermometer in (7), and in addition, shall include the following:
(1) A record of the time during which the FDD is in the forward-flow position.
(2) The cut-in and cut-out milk temperatures, recorded daily by the operator, at the be-ginning of the run (HTST only), and initialed quarterly by the Regulatory Agency.
(3) Number (6) from above shall also be recorded immediately after a chart has been changed.
NOTE: The temperature shown on the recording thermometer chart shall be used to determine that the required temperature for milk products containing higher fat and/or sweeteners has been achieved.
Continuous Flow Pasteurizers or Aseptic Processing Equipment with Magnetic Flow Meter Based Timing Systems: Flow rate recording charts shall be capable of continuously recording flow at the flow alarm set point and at least 19 liters (5 gallons) per minute higher than the high flow alarm setting. Flow rate recording charts shall contain all the information specified in Subitem a. above, except (3), (4), (5), (6), and (7), and in addition, shall include the following:
(1) A continuous record of the time during which the FDD, valve or system is in the forward-flow position.
(2) A continuous record of the flow rate.
Aseptic Processing Systems: Recording thermometer charts shall contain all the information specified in Subitem a. above, except 4, 5 and reference to the airspace thermometer in item 7. In addition these records shall include Subitem c. above, if applicable, and the following:
(1) A continuous record of the time during which the FDD, valve or system is in the forward-flow position.
(2) A continuous record of applicable regenerator pressures.
(3) Not later than one (1) working day after the actual process, and before shipment or release for distribution, a representative of plant management, who is qualified by suitable training or experience, shall review all processing and production records for completeness and to ensure that the product received the schedule process. The records, including the recording thermometer chart(s), shall be signed or initialed and dated by the reviewer.
(4) Number (6) from above shall also be recorded immediately after a chart has been changed.
EQUIPMENT TESTS AND EXAMINATIONS
The Regulatory Agency shall perform the indicated tests on the following instruments and devices initially on installation; and at least once each three (3) months and the remaining days of the month in which the equipment tests are due; and whenever any alteration or replacement is made which may affect the proper operation of the instrument or device. Provided, that the holding time test shall be conducted at least every six (6) months and the remaining days of the month in which the equipment check is due.
On an emergency basis, pasteurization equipment may be tested and temporarily sealed by a dairy plant employee provided the following conditions are met:
The individual applying the seal(s) is employed in a supervisory capacity by the plant in which the seal was removed;
The individual has satisfactorily completed a course of instruction, acceptable to the Regulatory Agency, on test controls for pasteurization equipment that includes a minimum of eight (8) hours classroom instruction;
The individual has demonstrated the ability to satisfactorily conduct all pasteurization control tests, in the presence of a regulatory official, within the past year;
The individual is in possession of authorization from the Regulatory Agency to perform these tests;
The individual will immediately notify the Regulatory Agency of the time of the shutdown that would necessitate the removal of the regulatory seals. Permission to test and seal the equipment must be obtained for each specific incident. The individual will also notify the Regulatory Agency of the identity of the controls affected, the cause, if known, of the equipment failure, the repairs made and the results of testing. The individual will provide the identity and volume of products processed during the period that temporary seals were applied to the Regulatory Agency;
If regulatory tests reveal that equipment or controls are not in compliance with the provisions of this Ordinance, all products that were processed during that period will be recalled;
The Regulatory Agency or a properly trained regulatory official, commissioned by the responsible State, of each participating non-U.S. country or political subdivision thereof, will remove the temporary seals, retest the equipment and apply regulatory seals within three (3) working days of notification by industry; and
No Grade "A" dairy products will be processed after three (3) working days without the affected equipment being tested and sealed by the Regulatory Agency or a properly trained regulatory official, commissioned by the responsible State, of each participating non-U.S. country or political subdivision thereof.
| Table 4. Equipment Tests - Batch, HTST, HHST and Aseptic Processing Systems | ||
|---|---|---|
| 1. | Vat, HTST, HHST, Aseptic indicating and airspace thermometers | Temperature accuracy |
| 2. | Vat, HTST, HHST, Aseptic recording thermometer | Temperature accuracy |
| 3. | Vat, HTST, HHST, Aseptic recording thermometer | Time accuracy |
| 4. | Vat, HTST, HHST, Aseptic indicating and recording thermometer | Recording vs. Indicating thermometer |
| 5.1 | HTST, HHST FDD | Leakage pass FDD |
| 5.2 | HTST, HHST FDD | FDD freedom of movement |
| 5.3 | HTST, HHST FDD | Device assembly (single stem) |
| 5.4 | HTST, HHST FDD | Device assembly (dual stem) |
| 5.5 | HTST FDD | Manual diversion |
| 5.6 | HTST, HHST FDD | Response time |
| 5.7 | HTST, HHST FDD | Time delay (inspect) |
| 5.8 | HTST, HHST FDD | Time delay (CIP) |
| 5.9 | HTST FDD | Time delay (leak-detect flush) |
| 6. | Vat leak protector valve(s) | Leakage |
| 7. | HTST indicating thermometers | Response time |
| 8. | HTST recording thermometers | Response time |
| 9.1 | HTST pressure switches | Regenerator pressures |
| 9.2.1 | HTST, HHST, Aseptic differential pressure controllers | Calibration |
| 9.2.2 | HTST differential pressure controllers | Regenerator pressure |
| 9.2.3 | HHST and Aseptic differential pressure controllers | Regenerator pressure |
| 9.3.1 | HTST booster pump/FDD | Inter-wiring check |
| 9.3.2 | HTST booster pump/metering pump | Inter-wiring check |
| 10.1 | HTST FDD | Temperature cut-in/cut-out |
| 10.2 | HHST FDD, Aseptic divert system (indirect heat) | Temperature cut-in/cut-out |
| 10.3 | HHST FDD, Aseptic divert system (direct heat) | Temperature cut-in/cut-out |
| 11.1 | HTST holding tubes/timing pumps (except magnetic flow meter based timing systems) | Holding time |
| 11.2.a | HTST holding tubes/magnetic flow meter based timing systems | Holding time |
| 11.2.b | HTST, HHST, Aseptic magnetic flow meter based timing systems | Flow alarm |
| 11.2.c | HTST, HHST, Aseptic magnetic flow meter based timing systems | Loss of signal/low flow |
| 11.2.d | HTST magnetic flow meter based timing systems | Flow rate cut-in/cut-out |
| 11.2.e | HTST magnetic flow meter based timing systems | Time delay |
| 11.3 | HHST holding tubes indirect heat | Holding time |
| 11.4 | HHST holding tubes direct injection heat | Holding time |
| 11.5 | HHST holding tubes direct infusion heat | Holding time |
| 12.1 | HHST, Aseptic systems indirect heating | Sequence logic |
| 12.2 | HHST, Aseptic systems direct heating | Sequence logic |
| 13. | HHST, Aseptic systems | Pressure in the holding tube |
| 14. | HHST, Aseptic systems using direct injection heating | Pressure differential across injector |
| 15. | Vat, HTST, HHST, Aseptic (all electronic controls) | Electro-Magnetic Interference |
All raw milk and milk products shall be maintained at 7°C (45°F) or less until processed. All pasteurized milk and milk products, except those to be cultured, shall be cooled immediately prior to filling or packaging, in approved equipment, to a temperature of 7°C (45°F) or less. All pasteurized milk and milk products shall be stored at a temperature of 7°C (45°F) or less. On delivery vehicles, the temperature of milk and milk products shall not exceed 7°C (45°F). Every room or tank in which milk or milk products are stored shall be equipped with an accurate ther-mometer. Provided, that aseptically processed milk and milk products to be packaged in hermetically sealed containers shall be exempt from the cooling requirements of this Item.
When milk is not cooled within a reasonable time, after it is received at the pasteurization plant, its bacterial content will be materially increased. The same reasoning applies to cooling the milk and milk products after pasteurization.
This Item is deemed to be satisfied when:
All raw milk and milk products are maintained at 7°C (45°F) or less until processed.
All pasteurized milk and milk products, except those to be cultured, are cooled immediately in approved equipment prior to filling and packaging to a temperature of 7°C (45°F) or less. All pasteurized milk and milk products shall be stored at a temperature of 7°C (45°F) or less. On delivery vehicles, the temperature of milk and milk products shall not exceed 7°C (45°F).
Each refrigerated room in which milk or milk products are stored, except aseptically processed milk and milk products, is equipped with an indicating thermometer that complies with the applicable specifications of Appendix H. Such thermometer shall be located in the warmest zone of the refrigerated room.
Each storage tank shall be equipped with an indicating thermometer, the sensor of which shall be located to permit the registering of the temperature of the contents when the tank contains no more than twenty percent (20%) of its calibrated capacity. Such thermometer shall comply with the applicable specifications of Appendix H.
All surface coolers comply with the following specifications:
The sections of open-surface coolers shall be so installed as to leave a gap of at least 6.4 millimeters (0.25 inches) between the header sections to permit easy cleaning.
Where header ends are not completely enclosed within the cooler covers, condensation or leakage from the headers shall be prevented from entering the milk or milk products by so shaping the exposed header faces, above and below all gaps, that condensation is directed away from the tubes, and by using deflectors at the bottom of the headers; or by shortening the bottom of the headers; or by shortening the bottom trough; or by some other approved method.
The location of supports of cooler sections shall prevent condensation and leakage from entering the milk or milk products.
All open-surface coolers shall be provided with tight-fitting shields that protect the milk and milk products from contamination by insects, dust, drip, splash or manual contact.
Recirculated cooling water, which is used in coolers and exchangers, including those systems in which a freezing point depressant is used, is from a safe source and protected from contamination. Such water shall be tested semiannually and shall comply with the Bacteriological Standards of Appendix G. Samples shall be taken by the Regulatory Agency and examination shall be conducted in an Official Laboratory. Recirculated cooling water systems, which become contaminated through repair work or otherwise, shall be properly treated and tested before being returned to use. Freezing point depressants and other chemical additives, when used in recirculating systems, shall be nontoxic under conditions of use.
Bottling and packaging of milk and milk products shall be done at the place of pasteurization in a sanitary manner by approved mechanical equipment.10
Manual bottling and packaging is very apt to result in the exposure of the milk and milk products to contamination, which would nullify the effect of pasteurization. The transfer of milk from the place of pasteurization to another plant for bottling subjects the pasteurized product to unnecessary risks of contamination.
This Item is deemed to be satisfied when:
All milk and milk products, including concentrated milk and milk products, are bottled and packaged at the plant where final pasteurization is performed. Such bottling and packaging shall be done without undue delay following final pasteurization.
All bottling or packaging is done on approved mechanical equipment. The term "approved mechanical equipment" shall not be interpreted to exclude manually operated machinery, but is interpreted to exclude methods in which the bottling and capping devices are not integral within the same system.
All pipes, connections, defoaming devices and similar appurtenances shall comply with Items 10p. and 11p. of this Section. Milk and milk products from continuous defoamers are not returned directly to the filler bowl.
Bottling or packaging machine supply tanks and bowls are equipped with covers that are constructed to prevent any contamination from reaching the inside of the filler tank or bowl. All covers shall be in place during operation.
A drip deflector is installed on each filler valve. Drip deflectors shall be designed and adjusted to divert condensation away from the open container.
Container in-feed conveyors to automatic bottling or packaging machines have overhead shields to protect the bottles or packages from contamination. These shields shall extend from the bottle washer discharge to the bottle feed-star, or in the case of single-service packaging machines, from the forming unit discharge to the filling unit and from the filling unit to the closure unit. Overhead shields shall be required on can in-feed conveyors when the cans are fed to the filler with the covers off.
Container coding/dating devices are designed, installed and operated such that the coding/dating operations are performed in a manner that open containers are not subjected to contamination. Shielding shall be properly designed and installed to preclude contamination of open containers.
Container fabricating materials, such as paper stock, foil, wax, plastic, etc., are handled in a sanitary manner and protected against undue exposure during the package assembly operation.
Bottling and packaging machine floats are designed to be adjustable without removing the cover.
The filler pipe of all bottling and packaging machines have a diversion apron or other acceptable device, as close to the filler bowl as possible, to prevent condensation from entering the inside of the filler bowl.
Filling cylinders on packaging machines are protected from contamination by overhead shields. When lubricants are used on filler pistons, cylinders or other milk-contact surfaces, the lubricant shall be food-grade and applied in a sanitary manner.
In the case of aseptic processing systems, the product shall be aseptically filled into sterilized containers and hermetically sealed in conformance with the applicable requirements of 21 CFR 113.
Capping or closing of milk and milk product containers shall be done in a sanitary manner by approved mechanical capping and/or closing equipment. The cap or closure shall be designed and applied in such a manner that the pouring lip is protected to at least its largest diameter and, with regard to fluid product containers, removal cannot be made without detection.
Hand capping exposes the milk to contamination. A cover extending over the pouring lip of the container protects it from contamination during subsequent handling, and prevents the sucking back into the bottle, by temperature contraction, of any contaminated liquid on the cap, including milk that has been forced out by temperature expansion and may have become contaminated. Caps or closures that are applied in such a manner that they cannot be removed without detection help to assure the consumer that the milk and milk products have not been contaminated after packaging.
This Item is deemed to be satisfied when:
The capping or closing of milk and milk product containers is done in a sanitary manner on approved mechanical capping/closing equipment. The term "approved mechanical capping and/ or closing equipment" shall not exclude manually operated machinery. Hand capping shall be prohibited. Provided, that if suitable mechanical equipment, for the capping or closing of container(s) of 12.8 liters (3 gallons) or more is not available, other methods which eliminate all possibility of contamination may be approved by the Regulatory Agency.
Bottles and packages that have been imperfectly capped or closed are emptied immediately into approved sanitary containers. Such milk or milk products shall be protected from contamination, maintained at 7°C (45°F) or less and subsequently repasteurized or discarded.
All caps and closures are designed and applied in such a manner that the pouring lip is protected to at least its largest diameter and, with respect to fluid product containers, removal cannot be made without detection. Single-service containers are so constructed that the product and the pouring and opening areas are protected from contamination during handling, storage and when the containers are initially opened.
All caps and closures are handled in a sanitary manner. The first cap from each tube, the first lap(s) from each roll of cap or cover stock and the first sheet of parchment or cover paper shall be discarded. The subsequent use of loose caps that are left in the cappers at the end of an operating period, after removal from the cap tubes, shall be a violation of this item, provided, that loose plastic caps and closures supplied by the manufacturer in plastic bags may be returned to storage in a protective wrap if removed from a hopper/descrambler immediately after a production run. Plastic caps and closures remaining in the chute between the hopper and the capping device shall be discarded.
Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination. No employee shall resume work after visiting the toilet room without thoroughly washing their hands. All persons, while engaged in the handling, processing, pasteurization, storage or transportation of milk, milk products, containers, utensils and equipment shall wear clean outer garments. All persons, while engaged in the processing of milk or milk products shall wear adequate hair coverings and shall not use tobacco.
Clean clothing and clean hands, including clean fingernails, reduce the possibility of milk, milk products, containers, utensils and equipment becoming contaminated.
This Item is deemed to be satisfied when:
Hands are thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination.
Each employee washes their hands following a visit to the toilet room and prior to resuming work.
All persons while engaged in the handling, processing, pasteurization, storage or transportation of milk, milk products, containers, utensils and equipment wear clean outer garments.
The use of tobacco products is prohibited in all rooms in which milk or milk products are handled, processed or stored, or in which milk containers, utensils and equipment are washed. These rooms shall include, but are not limited, to the receiving, processing, packaging, product storage, cooling and dry storage ingredients, single-service article storage and container/utensil wash-up areas. Any person engaged in the processing of milk or milk products wears adequate head coverings.
All vehicles used for the transportation of pasteurized milk and milk products shall be constructed and operated so that the milk and milk products are maintained at 7°C (45°F) or less and are protected from contamination.
Milk and milk products, as well as empty containers, should be protected against contamination at all times.
This Item is deemed to be satisfied when:
All vehicles are kept clean.
Material that is capable of contaminating milk or milk products is not transported with milk or milk products.
Vehicles have fully enclosed bodies with well-fitted, solid doors.
Milk plant surroundings shall be kept neat, clean and free from conditions which might attract or harbor flies, other insects and rodents or which otherwise constitute a nuisance.
The surroundings of a dairy plant should be kept neat and clean to prevent attracting rodents, flies and other insects, which may contaminate the milk or milk products. Insecticides and rodenticides, not approved for use in dairy plants, or approved insecticides and rodenticides, not used in accordance with label recommendations, may contaminate the milk or milk products processed by the dairy plant.
This Item is deemed to be satisfied when:
There is no accumulation of trash, garbage or similar waste in areas adjacent to the milk plant. Waste material stored in suitable covered containers shall be considered in compliance.
Driveways, lanes and areas serving milk plant vehicular traffic are graded, drained and free from pools of standing water.
Outdoor areas for milk tank truck unloading are constructed of smooth concrete or equally impervious material, properly sloped to drain and equipped with trapped drains of sufficient size.
Only insecticides and rodenticides that are approved for use by the Regulatory Agency and/or registered with EPA shall be used for insect and rodent control.
NOTE: Appendix M. provides a source for milk plants receiving stations and transfer station inspection forms, which summarize the applicable sanitation requirements of this section.