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U.S. Department of Health and Human Services
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Single-service containers and closures have been used in the dairy industry for many years. Industry applied quality assurance controls for manufacturing and handling of the materials have made it possible for these products to reach the point of use in a sanitary condition free from toxic materials, which may migrate into milk or milk products.
Within recent years, single-service container manufacturers have introduced new materials, equipment, and design concepts for these containers and closures. Evaluation of the industry's basic manufacturing and handling techniques and establishment of sanitation criteria assure that single-service containers and closures and the materials from which they are formed are safe and in compliance with bacteriological standards of Item 12p. of this Ordinance.
The use of these standards will ensure the production of sanitary containers and closures for milk and milk products, as defined in this Ordinance.
These standards shall apply to all blank fabricators, converters, printers, closure manufacturers, plastic laminators, sheet formers, blow molders, vacuum formers, plastic extruders, injection molders, preformers, manufacturers of valves, tubes, dispensing devices, and sample containers and similar plants. These also apply to the installation, operation, cleaning, sanitization and maintenance of equipment used in compounding materials for the fabrication, production, handling and storage of single-service containers and closures.
Milk and food plants manufacturing and/or selling containers to other milk or milk products plants as defined in thisOrdinance shall meet all the requirements of these standards. These requirements shall not apply to paper mills or resin manufacturing plants.
Grade "A" milk and milk product plants as defined in thisOrdinance shall use single-service containers and closures from plants certified in the latest semi-annual publication of theSanitation Compliance and Enforcement Ratings of Interstate Milk Shippers (IMS List).
The following definitions shall be employed in the application of these sanitation standards:
"Single-Service Container" shall mean any container having a milk or milk product-contact surface and used in the packaging, handling or storage of Grade "A" milk and milk products which is intended for one use only.
"Closure" shall mean a cap, lid, seal, tube, valve, lid material or other device in or on a container used for the purpose of enclosing or dispensing the contents.
"Paper Stock" shall mean any paper made from the following materials:
Paper and paperboard manufactured from clean, sanitary virgin chemical or mechanical pulp or from "broke and trim" of such paper and paperboard, provided they have been handled, treated and stored in a clean, sanitary manner, or reclaimed fiber using acceptable or approved protocol in compliance with 21 CFR 176.260; and
Components meeting the requirements of the FFD&CA as amended.
"Broke and Trim" shall mean paper and paperboard that have been discarded anywhere in the process of manufacture, such as on paper-making machines in the form of trim. This may also include unprinted trim from the converting process, provided the trim has been handled, treated and transported in a clean, sanitary manner.
"Plastic Molding, Forming, Extrusion, and Laminating Resins" shall mean:
Resins or an intimate admixture of resins with other ingredients which meet the requirements of the FFD&CA as amended; and
Plastic composed solely of clean cuttings or regrind, provided they have been handled and maintained in a clean, sanitary manner.
This definition shall not preclude the use of recycled plastic material when it complies with a protocol that has been reviewed and accepted by FDA.
"Regrind" shall mean clean plastic material, that is trimmed from the container or closure, and imperfectly formed containers or closures, which result from the manufacture of single-service containers and closures, provided it is handled in a clean, sanitary manner. This may be in its trimmed or molded form and ground in a suitable grinder within the plant. It shall not include any material, container or closure which comes from an unapproved source or whose source, chemical content or treatment is unknown, or which may have poisonous or deleterious material retained in the plastic, which migrates to the food at levels exceeding regulatory levels. Regrind, when transported from one (1) approved plant to another, will be shipped in suitable, clean, sealed, properly labeled containers. This definition shall not preclude the use of regrind plastic material when it complies with a protocol that has been reviewed and accepted by FDA.
"Production Scrap" shall mean material which remains from the manufacture of single-service containers or closures, that has been handled or treated in such a manner that it does not comply with the definition for "broke and trim" or "regrind", but may be collected for recycling. It may contain material such as containers or trim that have fallen on the floor.
"Coatings" shall mean any layer or covering which is applied to the product-contact surface.
"Product-Contact Surface" shall mean those surfaces of the container or closure that the product comes in contact with.
"Nontoxic Materials" shall mean materials that are free of substances, which may render the milk injurious to health or which may adversely affect the flavor, odor, composition or bacteriological quality of the product and meet the requirements of the FFD&CA as amended.
"Metals" shall mean those metals that are nontoxic, nonabsorbent and corrosion-resistant under conditions of intended use.
"Sanitization" shall mean the application of any effective method or substance to a clean surface for the destruction of pathogens and of other microorganisms as far as is practicable. Such treatment shall not adversely affect the equipment, the milk or milk product, or the health of consumers. Chemical sanitizers shall meet the requirements contained in Part I of Appendix F of this Ordinance.
"Single-Service Articles" shall mean articles that are constructed wholly, in part, or in combination from paper, paperboard, molded pulp, plastic, metals, coatings or similar materials and intended by the manufacturer for one (1) usage only.
"Preformed Container" shall mean a container in completed form ready for filling.
"Manufacturer" shall mean any person or company in the business of manufacturing a single-service container or closure for use by a milk plant for the packaging of a finished Grade "A" milk or milk product.
"Component Part" shall mean any item that by itself, does not perform any function, but when assembled with one (1) or more component parts or closures, becomes a part of the single-service container or closure. These may include, but are not limited to blanks, sheeting, filling valve parts, tubes, dispensing devices and sampling containers. All material used for fabrication of a component part must meet the requirements of the FFD&CA as amended.
"Sample Set" shall mean:
For the rinse test, a minimum of four (4) containers shall be tested.
For the swab test, a minimum of four (4), 50 square centimeter areas of surface from separate containers shall be tested. In the case of containers or closures with a product-contact surface area smaller than 50 square centimeters, more than four (4) containers or closures to equal at least 50 square centimeters times four (4) will be required to be swabbed.
"Manufacturing Line" shall mean a manufacturing process such as extrusion, blow-mold, etc.
Paper stock shall meet the bacteriological standard of not more than two hundred fifty (250) colonies per gram as determined by the disintegration test. The paper stock supplier shall certify that their paper stock was manufactured in compliance with this Standard. This applies only to the paper stock prior to lamination.
Where a rinse test can be used, the residual microbial count shall not exceed fifty (50) per container, except that in containers less than 100 mL, the count shall not exceed ten (10), or not over fifty (50) colonies per 8 square inches (1 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 and closures shall be free of coliform organisms.
During any consecutive six (6) months, at least four (4) sample sets shall be collected in at least four (4) separate months, except when three (3) months show a month containing two (2) sampling dates separated by at least twenty (20) days, and analyzed at an Official, Commercial or Industry Laboratory approved by the State Milk Laboratory Certifying Agency specifically for the examinations required under these Standards. (See Item 12p. of this Ordinance for sampling of containers and closures in pasteurization plants).
When a single-service container or closure is made from one (1) or more component parts as defined in this document, only those final assembled products that may have product-contact surface(s), must be sampled and tested for compliance with Section C.
Procedures for obtaining samples and for the laboratory examination of these products are contained in the latest edition of SMEDP and shall be in substantial compliance with these methods. Such procedures and examinations shall be evaluated in accordance with the current revision of the EML. A list of approved laboratories may be found inthe IMS List which is published semiannually by FDA.
NOTE: To be used in conjunction with Form FDA 2359c, "Single-Service Manufacturing Plant Inspection Report" (See Appendix M.)
FLOORS
The floor shall be smooth, impervious, and maintained in a state of good repair.
The joints between the walls and floor shall be tight, impervious and shall have coved or sealed joints.
Where floor drains are provided, they shall be properly trapped and floors sloped to drain.
WALLS AND CEILINGS
Walls and ceilings of fabricating areas shall have a smooth, cleanable, light-colored surface.
Walls and ceilings in fabricating and storage areas shall be kept in
good repair.
DOORS AND WINDOWS
All outside openings shall be effectively protected against the entry of insects, rodents, dust and airborne contamination.
All outer doors shall be tight and self-closing.
LIGHTING AND VENTILATION
All rooms shall be adequately lighted either by natural light, artificial light, or both. A minimum of twenty (20) foot-candles should be maintained in fabricating areas and five (5) foot-candles in storage areas. Packaging, sealing, wrapping, labeling and similar procedures are considered part of the fabricating area.
Ventilation shall be sufficient to prevent excessive odors and the formation of excessive water condensation.
The intake of all pressure ventilation systems in fabricating areas, whether they are positive or exhaust shall be properly filtered.
SEPARATE ROOMS
All fabricating areas shall be separate from non-fabricating areas to protect against contamination. Provided, that if the entire plant meets all sanitation requirements and no source of cross contamination exists, separation between areas is not required.
All regrinding of plastic and the shredding, packaging or baling of paper trim shall be conducted in rooms separate from the fabricating room, except that they may be conducted within a designated area of the fabricating room, provided such operations are kept clean and free of dust.
TOILET FACILITIES - SEWAGE DISPOSAL
Disposal of sewage and other wastes shall be in a public sewage system or in a manner in compliance with Local and State regulations.
All plumbing shall comply with the Local and State plumbing regulations.
Toilet rooms shall have solid, self-closing doors and shall not open directly into fabricating areas.
The toilet room and fixtures shall be maintained in a clean and sanitary condition and kept in good repair.
Each toilet room shall be well lighted and adequately ventilated. Air ventilation ducts from toilet facilities shall vent to the outside.
Proper handwashing facilities shall be provided in toilet rooms.
All windows shall be effectively screened when open.
Signs shall be posted in all toilet rooms reminding employees to wash their hands before returning to work.
Eating and/or storage of food are prohibited in toilet rooms.
WATER SUPPLY
The water supply, if from a public system, shall be approved as safe by the State Agency responsible for water quality, and in the case of individual water systems, comply with at least the specifications outlined in Appendix D of this Ordinance.
There shall be no cross-connection between a safe water supply and any unsafe or questionable water supply or any source of pollution through which the safe water supply might become contaminated.
Samples for bacteriological testing of individual water supplies are taken upon the initial approval of the physical structure; each twelve (12) months thereafter; and when any repair or alteration of the water supply system has been made. The examination of the sample shall be conducted in an officially designated laboratory.
HANDWASHING FACILITIES
Hot and cold and/or warm running water, soap, air dryers or individual sanitary towels shall be convenient to all fabricating areas. Provided, that solvent or soft soap dispensers, containing sanitizers, may be used if water is not available. When individual sanitary towels are used, covered trash containers shall be provided.
Handwashing facilities shall be kept clean.
PLANT CLEANLINESS
The floors, walls, ceilings, overhead beams, fixtures, pipes and ducts of production, storage, regrind, baling and compacting rooms shall be clean.
All production areas, warehouse, toilet, lunch and locker rooms shall be free of evidence of insects, rodents, and birds.
Machines and appurtenances shall be kept clean. Provided, that minor accumulations of paper, plastic or metal dust and other production soils incidental to normal fabricating operations do not violate this requirement.
LOCKER AND LUNCHROOMS
Locker and lunchrooms shall be separate from plant operations and be equipped with self-closing doors.
Eating and/or storage of food are prohibited in fabricating and storage areas.
Locker and lunchrooms shall be kept in a clean and sanitary condition.
Cleanable refuse containers, properly labeled, shall be provided, which are covered, impervious, leak-proof and readily accessible.
Proper handwashing facilities shall be convenient to locker rooms and lunchrooms.
Signs shall be posted reminding employees to wash their hands before returning to work.
DISPOSAL OF WASTES
All refuse and garbage shall be stored in covered, impervious and leak-proof containers. This requirement does not pertain to production scrap.
All waste containers shall be clearly labeled for their intended purpose and contents.
Where possible, garbage and assorted rubbish should be stored outside the building in covered, impervious, cleanable containers. If stored inside the building, it must be contained in similar receptacles, but in an area separate from fabricating areas.
PERSONNEL-CLEANLINESS
Hands shall be thoroughly washed before commencing plant functions and as often as may be required to remove soil and contamination, and before returning to work after visiting the toilet room or lunchroom.
All personnel shall wear clean outer garments and effective hair restraints.
No person affected with any disease in a communicable form, or while a carrier of such disease, and no person with an infected cut or lesion shall work in any processing area in any capacity where there is a likelihood of such person contaminating product or product-contact surfaces with pathogenic organisms. (See Section 13 and 14 of this Ordinance).
The use of tobacco products is prohibited in fabricating, regrind and storage areas.
PROTECTION FROM CONTAMINATION
Upright, open formed containers and closures shall be protected from contamination by the use of overhead shields.
Whenever air under pressure is directed at resin or a product-contact surface, it shall be free of oil, dust, rust, excessive moisture, extraneous materials and odor and shall otherwise comply with the applicable requirements of Appendix H of this Ordinance.
Air that is directed at product or product-contact surfaces by fans or blowers shall be filtered and shall otherwise comply with the applicable requirements of Appendix H of this Ordinance.
Only pesticides approved for use in food plants and registered with the EPA shall be used for insect and rodent control.
Pesticides shall be used in accordance with the manufacturer's directions and used so as to preclude the contamination of containers or closures.
STORAGE OF FINISHED PRODUCT AND MATERIAL IN PROCESS
Blanks, roll stock and all other single-service containers, closures and articles shall be stored in a manner to provide protection from contamination by use of pallets, slip-sheets or other methods and away from any wall a sufficient distance to facilitate inspection, cleaning and pest control activities. Any roll stock having dirty or soiled outer turns and/or edges shall have sufficient turns discarded prior to use and the edges trimmed to provide protection from contamination.
Single-service articles in process shall be protected from contamination by use of a single-service cover sheet or other protective device. This includes chip-board, dividers, separators, bags and other items that can become contact surfaces.
Appropriate clean, dry storage facilities shall be provided for single-service containers, closures, paper for wrapping, adhesives, blanks and other production material to provide protection from splash, insects, dust and other contamination.
Where containers and closures are pre-formed in plants other than the original fabricating facility:
(1) Containers, blanks and closures shall be stored in the original cartons and sealed until used; and
(2) Partially used cartons of containers, blanks and closures shall be resealed until used.
Containers used for the storage of resin, regrind, broke and trim, intended for reuse, shall be covered, clean, impervious and properly identified. Reuse of storage containers, such as gaylords, is permitted provided plastic liners are used.
In-process storage bins that touch the product-contact surface of containers or closures shall be constructed of cleanable, nonabsorbent material and kept clean.
FABRICATING, PROCESSING AND PACKAGING EQUIPMENT
The requirements of this Section pertain to all equipment and processes used in the fabrication of containers and closures, irrespective of the materials used and whether or not mentioned herein. Some of this equipment includes grinders, rollers, reamers and cutters, molders and fittings, extruders, silos, resin bins and hoppers, printing equipment, blanking equipment and sealing equipment.
Rolls, dies, belts, tables, mandrels, transfer tubing and all other contact surfaces shall be kept clean, sanitary and reasonably free of accumulation of paper, plastic or metal dust and other production soils. Equipment designed for milk plant use, which is utilized for pre-forming containers, shall be clean and sanitized prior to operation.
All materials in process for containers and closures shall be protected from contamination by condensate or dripping from overhead pipes or equipment components.
Makeshift devices such as tape, rope, twine, paperboards, etc., shall not be used. All fasteners, guides, hangers, supports and baffles shall be constructed of impervious, cleanable materials and kept in good repair.
Take-off tables and other container contact surfaces shall be constructed of cleanable material, kept clean and in good repair.
Waxing shall be performed so as to assure that containers or closures are completely coated and the wax shall be kept at a temperature of 60øC (140øF) or higher.
All grinders, shredders and similar equipment used for regrinding shall be installed above the floor or installed in such a manner that they are protected, so that floor sweepings and other contaminants cannot enter the grinder or shredder.
Storage tanks, silos, gaylords or bins used for plastic resins shall be so constructed to protect the resin from contamination. All air vents shall be filtered to prevent the entrance of dust or dirt. Air tubes used to conduct resin shall be supported above ground to prevent their becoming submerged in water. Air tubes used to convey resin shall have end caps, attached by chain or cable, that prevent contamination. This Item also applies to all raw materials handled in like manner.
EQUIPMENT AND MATERIALS FOR CONSTRUCTION OF CONTAINERS AND CLOSURES
Single-service containers and closures for milk and milk products shall not be fabricated on equipment used for the manufacture of products made of non-food-grade materials, unless such equipment has been thoroughly cleaned and/or purged of all non-food-grade material by a process that will not contaminate the food-grade material.
Only plastic sheeting and extrusions, plastic laminated paper, metal and paperboard blanks, or combinations thereof, from a manufacturing and/or fabricating plant conforming to these standards, shall be used. Fabricating plants listed in the current IMS List shall be considered in compliance with this Item.
Only sanitary, nontoxic lubricants shall be used on container-closure contact surfaces. Excess lubricant shall be removed from surfaces close to shafts, rollers, bearing sleeves and mandrels. These lubricants shall be handled and stored in a manner that will prevent cross contamination with non-food-grade lubricants. Such storage areas shall be clean and adequately ventilated.
The manufacture of single-service containers and closures for milk and milk products shall be carried on in such a manner that there will be no cross contamination of raw material or regrind with non-food-grade materials.
Containers, resin and flashing on the floor and floor sweepings of production materials are prohibited from being reused. This shall not preclude the use of these materials when it complies with a protocol that has been reviewed and accepted by FDA.
WAXES, ADHESIVES, SEALANTS AND INKS
Waxes, adhesives, sealants and inks used for containers and closures shall be handled and stored in a manner that will prevent cross contamination with similar non-food-grade materials. Such storage areas shall be clean and adequately ventilated.
Unused materials shall be covered and properly stored.
Waxes, adhesives, sealants and inks shall not impart odor or taste to the milk or milk products and shall not contaminate the product with microorganisms or toxic or injurious substances. All materials that are applied to the product-contact surface shall comply with the requirements of 21 CFR Parts 175-178.
Transfer containers shall be kept clean and shall be properly identified and covered.
HANDLING OF CONTAINERS AND EQUIPMENT
Handling of fabricated containers, and container and closure-contact surfaces shall be kept to a minimum. Handlers shall sanitize their hands frequently or wear clean, single-use gloves.
WRAPPING AND SHIPPING
Blanks, closures, halves, nested or pre-formed containers and parts such as valves, hoses, tubes and other fittings shall be properly packaged or containerized prior to shipping.
The outer package or containerized units shall protect the contents from dust and other contamination.
Transportation vehicles used to ship finished materials from the single-service container or closure plant or within the plant shall be clean and in good repair and shall not have been used for the transportation of garbage, waste or toxic materials.
Paperboard containers, wrappers, and dividers that contact the surface of the container or closure shall not be reused for this purpose.
All packaging materials that contact the product-contact surface of the container or closure shall comply with the requirements of 21 CFR Parts 175-178 and the bacteriological standards of Section C of these Standards, but the materials do not have to be manufactured at a listed single-service plant.
IDENTIFICATION AND RECORDS
Outer wrappings shall be identified with the name and city of the plant where the contents are fabricated, except those manufactured in, and which are only for use in the same facility. In the cases where several plants are operated by one firm, the common firm name may be utilized, provided that the location of the plant at which the contents were fabricated is also shown either directly or by the FIPS numerical code on the outer wrapper.
Records of all required bacteriological tests of containers and closures shall be maintained at the plant of manufacture for two years and results shall be in compliance with Section C of these Standards.
The fabricating plant shall have on file information from suppliers of raw material, waxes, adhesives, sealants and inks indicating that the material complies with the requirements of 21 CFR Parts 175 - 178.
The fabricating plant shall have on file information from the suppliers of packaging materials specified in Section 19, Item e. of these Standards indicating that the material complies with the requirements of 21 CFR Parts 175-178 and the bacteriological standards of Section C of these Standards.
Multi-plant corporations may have all the required information at a central location as long as it can be transmitted to the site upon request.
SURROUNDINGS
Exterior surroundings shall be neat and clean and free from conditions that might attract or harbor flies, other insects and rodents.
Driveways, lanes and areas serving the plant vehicular traffic are graded, drained and free from pools of standing water.