Manufacturers - 2

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water level readings and chart readings. The computer system operates as a stand alone system using an industrial 386, or higher, computer as the microprocessor. The system is not designed to calculate new thermal processes in the event of a temperature drop. However, the system can be programmed to select alternate processes for temperature drops from a preprogrammed table of alternate processes. The system also can be programmed to use an Initial Temperature (IT) table to select the process time. FDAs determination that this system met the intent of the regulations was transmitted to Stock America via letter of September 1994.

At this time, these 3 computer systems are the only systems that have been reviewed and acknowledged by FDA, as meeting the intent of the lacf regulations for record keeping.

Other systems for computer control and record keeping for lacf are employed in the United States and in many foreign countries. When these systems are encountered, the investigator must thoroughly evaluate the system to determine it's function, and report on it in the EIR. If the firm does not have a letter from FDA contact HFS-617.

You must remember that a computerized record keeping system is still required to meet the intent of the regulations. Every item required to be on a written record by the lacf regulations must also be accounted for by a computerized record keeping system. The record should contain at least one comparison MIG thermometer reading taken during the thermal process and entered on the processing record by the operator (this information may be entered through a touch screen or key pad onto the computer record), the system must still be equipped with a continuous temperature recording chart, and all factors critical to the thermal process must be monitored and the observations recorded either on the computerized control record or on some other record that can be correlated with the computerized record. The record keeping functions of the computer controlled retort system must be documented sufficiently to allow for technical review of the system by the CFSAN.

POST PROCESS CONTAINER

HANDLING

COOLING

Air Cooling - Contamination of air cooled cans is more likely to occur if the cans are wet. Because air cooled cans are normally removed from a steam process without any exposure to water, this is not likely to occur. However, if wet items such as gloves or jackets are laid upon the cooling cans contamination may occur from these items. In addition to supplying the contaminating organisms the water on these items could give the organisms the motility required to penetrate the can through the seams. Typically, the seam compound would be in a state of flux during the beginning of this period, just as it would be with water cooling. At the same time the can is forming vacuum while cooling. An example of exposing air cooling cans to foreign objects would be the laying of water repellent jackets worn during fish evisceration across stacks of air cooling cans. Plant personnel should be instructed not to lay foreign objects on cans stacked for air cooling. Cans should be air cooled in areas protected from dripping and condensation, birds etc.

Thermophilic Growth - Optimum growth temperature for thermophiles is 131oF, with a range of 110oF to 170oF. Obviously, the interior of air cooled cans would be in this range at some point during cooling. Care should be taken to assure that air cooled cans be stacked so that air circulation is adequate to prevent holding of cans at thermophilic temperatures for long periods of time. While not a hazard to health, thermophiles can cause economic spoilage in the form of flat sour spoilage or swollen cans. Flat sour spoilage is so named because the can ends do not swell, but the product pH drops, giving the product an undesirable sour flavor. This can only be detected when the can is opened.

Water Cooling - Water cooled cans may be more susceptible to contamination because the cooling water may, in addition to supplying the organisms, also supply the motility needed for the organism to penetrate the can's seams. The seam compound is also more flexible and, therefore, less resistant to microbial penetration during the cooling cycle.

Cooling water should be chlorinated or otherwise adequately treated to kill organisms which may be found in the water so that if water leaks through the seam it will not carry any organisms into the can. However, the regulations (21 CFR 113.60(b)) only require chlorination of cooling canals and recirculated cooling water.

Cooling water temperature should be controlled to prevent cans from being cooled to too low a temperature, which would prevent proper drying and possibly result in can rusting. Cooling water that is too warm or premature removal of cans from the cooling water may cause thermophilic spoilage by allowing storage of cans in the thermophilic temperature range.

Cooling Canals - 21CFR 113.60(b) requires that

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