AUDIT CONTROL PROGRAM - BIOTEC FOODS
GOOD MANUFACTURING PROCEDURES
STANDARD OPERATING PROCEDURES MANUAL
DRIED POWDER AND GRANULAR PROCESSING, STORAGE AND REPACKAGING GUIDELINES
These "GUIDELINES" set forth acceptable practices in the manufacture, storage and repackaging of dried powders and granular forms for Bulk Dietary Supplement Powders and Pre-Mix Formulas.
Buildings and Environment
The premises should be clean, orderly, well drained, and free of potential pollutants such as dust, wastes, vermin, and other pests.
Buildings should be so constructed, screened, and maintained to prevent entry and harboring of birds, insects, and vermin.
Building interiors should have smooth and tight ceilings, floors, and walls, permitting effective cleaning and sanitation.
All rooms should be of sufficient size for their intended purpose and have adequate lighting to facilitate sanitation.
Liquid processing, dryer processing and dry product packaging operations should be appropriately separated, preferably in separate rooms.
Service areas, such as boiler rooms, tool room’s lavatories, dressing rooms, etc., should be separated from the processing areas.
Traffic in and out of all plant areas should be controlled and restricted. No traffic should be permitted between the unpasteurized side and pasteurized side of the process.
Adequate and convenient facilities should be provided for personnel cleanliness, and the cleaning and sanitizing of equipment. Appropriate waste disposal, including properly trapped floor drains should be available.
The plant should have a regularly tested, potable water supply, both hot and cold.
The plant air intakes should be adequately filtered and so located and fitted to prevent entrance of contamination including dirt and dust, and so constructed to discourage bird roosting.
The dry air exhausts from processing equipment should be passed through dust collectors to prevent product dust buildup on the premises.
Air used in processing should be adequately filtered to prevent entrance of foreign material and to maintain sanitary conditions.
Personnel Cleanliness and Practices
All plant personnel should be thoroughly instructed in plant sanitation guidelines, and the need for strict adherence to them. Key plant personnel should be trained as sanitary control officers to supervise sanitary practices.
Clean clothing, preferably white, and head covering should be put on after arriving at the plant, and worn in processing areas.
Only authorized personnel wearing suitable attire (as above) should be permitted in the processing area.
Persons with a communicable disease, or any other condition which could contaminate the product should be excluded from the entire plant.
Equipment and Utensils
Equipment should be easily accessible for cleaning and maintained in good repair and sanitary condition.
Effective cleaning methods and schedules should be adopted.
All product surface contact equipment should be washed and sanitized prior to use, and after each use. It should be washed and sanitized dally when operating on an 8 hour basis, and weekly when on a 6 day continuous schedule (more often when practical).
Cleaning materials and equipment (cleaners, disinfectants brushes, and other tools) should be properly identified stored, handled, and used in a manner to prevent contamination of the product.
The dry product handling system should be equipped with sanitary dust collection facilities. Dust collection units and filters should be changed as needed to prevent contamination of the premises and equipment.
Industrial vacuum cleaning units of sufficient capacity should be used for cleaning the plant interior, and the equipment, where applicable, daily. Separate units with attachments should be used exclusively for internal cleaning of equipment.
Indicating or recording thermometers should be used to check process and sterilization temperatures; temperature records of batches processed, and those which are sterilized should be maintained for 2 years after distribution is completed.
Raw Materials
Each raw material batch should be sampled and a copy of the vendor’s Certificate of Analysis indicating negative for pathogens and salmonella. Each raw material arriving without a vendor’s Certificate of Analysis should be sampled and a Chain of Custody Report/Pickup Sampling Summary completed for submission to the laboratory upon receipt. The approved laboratory analysis dried material protocol is as follows:
ANALYSIS DESCRIPTION METHOD
· MB1115G Microbial Limits USP (Screening Only) USP 26 thru Sup 2 <61>
· MB1116 Microbial Limits Screening USP 26 thru Sup 2 <61>
· MB1015 Plate Count, Aerobic, USP USP 26 thru Sup 2 <61>
· MB1093 Fungi USP 26 thru Sup 2 <61>
· MB1013 Staphylococcus aureus USP 26 thru Sup 2 <61>
· MB0110 Pseudomonas aeruginosa USP 26 thru Sup 2 <61>
· MB1006 E. coli USP USP 26 thru Sup 2 <61>
· MB0009 Salmonella, USP USP 26 thru Sup 2 <61>
The sample must be negative for all pathogens, especially salmonella. See below for more information on Sampling and Examination.
Dry Operations
1. Sifter screens should be removed and cleaned daily.
2. Hammer mill should be cleaned daily.
3. Floor sweepings and tailings should be collected and disposed of in a manner to preclude contamination of the finished product and plant facilities.
4. The product should be protected from moisture at all times.
Packaging
1. New or adequately cleaned and sanitized containers should be used.
2. A minimum amount of containers, protected from airborne contamination should be on hand during the bagging operation. An hour's supply should be sufficient.
3. Bags liners, or other finished product containers should be filled in such a manner to preclude employee contact with the inner surfaces, dust contamination, or other practices conducive to product contamination.
4. Packaging room should be moisture proof and dry.
Storage
1. Packaging materials should be stored and handled to protect them from dust, moisture, and other contamination.
2. The finished product should be protected from moisture, vermin, and other contamination during handling and storage.
Sampling and Examination
1. An adequate* microbiological control program covering periodic examination of raw materials, inline sampling finished product, and plant environmental samples should be maintained to detect seeding of the plant or equipment with Salmonella.* "Adequate" for this purpose cannot be clearly defined, and will depend on the total pattern of potential problems facing the firm, as well as the firm's history in regard to salmonella and other pathogenic contamination of product raw materials. Management is responsible for considering such factors and developing/modifying the manufacturing sampling points and protocols. Suggested improvements in current sampling and examination protocols should be directed in writing to the plant manager.
2. Finished product found to have a positive test for salmonella and other pathogenic contamination should be adequately sterilized and shown Salmonella (pathogen) negative by adequate testing, or disposed of (for nonfood and non-feed use) or destroyed.
3. A finished product batch testing positive for salmonella or other pathogenic contamination requires immediate action:
a. The Entire Batch should be segregated and quarantined immediately. The batch should be sterilized using a method authorized by the plant manager or (more likely) the batch should be disposed of using approved contaminated material handling methods and safety procedures.
b. Contact the plant manager immediately.
c. Cease All Production and Repackaging until the source of the contamination is identified and corrected.
d. Identify the source of contamination.
e. Take measures to eradicate the source of contamination.
4. Environmental samples, e.g. air filter material, equipment dust, floor sweepings, sifter tailings, and vacuum cleaner dust, should be examined for Salmonella as often as is practical.
OPTIONAL RAW MATERIAL/WORK-IN-PROCESS TESTING METHOD. (Not to be used with finished goods.)
UV LIGHT TESTING METHOD FOR SOME RAW MATERIALS (with a low incidence of contamination.)
NOTE: Containers for samples of unprocessed, intact seeds and desiccated malted seeds, or dehydrated sprouted seeds or grains must be sufficiently porous to provide for dissipation of moisture produced by respiration of the nut, seed, or grain.
Samples are to be collected from as many random sites in the lot as possible.
**Optional sampling program for seeds or dried fruit with a low incidence of contamination. Take initial 10 x 454 gm (1 lb) sample. If any aflatoxin or contamination is detected, resample 50 x 454 gm (1 lb) sample for determination of contamination level on which to base pass/no-pass judgment.