Manufacturers - 2

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Containers (NFPA Bulletin 26-L)

2. Thermal Processes For Low-Acid Foods in Glass Containers (Bulletin 30 -L)
3. Flexible Package Integrity Bulletin (Bulletin 41-L)
4. Guidelines for Thermal Process Development for Foods Packaged in Flexible Containers
5. Continuous Rotary Sterilizers-Design and Operation (Bulletin 44 -L)
6. Automatic Control Guidelines For Aseptic System Manufacturers and Companies Using Aseptic Processing and Packaging for Preserving Foods (Bulletin 43L)

DEIO also has a supply of Institute for Thermal Processing Specialists (IFTPS), 'Protocol for Carrying Out Heat Penetration Studies'.

The AOAC Chart 'Classification of Visible Can Defects (Exterior)' is helpful when performing field exams. Districts should have this chart available (usually the labs have them).

INVESTIGATOR ROLE

The investigator must be prepared during inspection of the lacf manufacturer to audit the firm's compliance with the lacf regulations. 21CFR Part 113.40 mandates that the equipment is the same as that upon which the temperature distribution studies were performed; and the firm is operating the thermal processing equipment in the manner prescribed by the regulations and the firms processing authority.

Prior to inspecting a lacf manufacturer the investigator should review the establishment files to determine if a diagram or detailed description of the firms retort system is on file. If a diagram or description is not on file, one should be obtained from the firm or prepared by the investigator during the inspection, and placed in the establishment files. If a previous diagram is used to audit the retort equipment care must be taken to insure that no changes have been made in the retort system.

The firm should be able to identify how the retort was plumbed at the time temperature distribution studies were performed, and any changes made since that time. Items such as pipe sizes, length of pipes, valve sizes, valve types, the holes in steam distribution pipes, retort dimensions, the holes in water distribution pipes, and differences between individual retort systems should be carefully measured, described and recorded. The retort diagram can then be used by the investigator and CFSAN personnel to determine if the retort system is in compliance with the lacf regulations. Changes in the retort system can be easily noted if a diagram was previously prepared and placed in FDA's files.

During the inspection the investigator must observe the thermal processing equipment for a sufficient amount of time (normally several retort cycles) to determine that the firms procedures and the retort operation is adequate to provide the filed scheduled thermal process.

The use and submission of form FDA 3146-DOMESTIC ACIDIFIED AND LOW-ACID CANNED FOODS INSPECTION REPORT and Form FDA 3146a, DOMESTIC LOW-ACID CANNED FOODS RETORT DATA SHEET (Processing in Steam in Still Retorts) is optional, but these forms can be used by the investigator to insure that all operations in the firm are covered. Copies of these forms are attached as Form 1 and 2, respectively.

lacf INSPECTION EQUIPMENT FOR INVESTIGATORS

To perform an inspection of an lacf manufacturer the FDA investigator needs a variety of equipment. This will include the equipment normally needed for a basic sanitation inspection as well as some specialized equipment. Cannery kits containing the majority of the required equipment should be available in each district. If the equipment is not available, the investigator may have to obtain it from the noted sources.

The basic equipment needed for a lacf inspection, in addition to a flashlight and camera consists of:

1. A stop watch for timing of wall clocks, temperature recording charts, retort vents, come-up times, thermal processes and other retort control functions. A wrist watch or pocket watch is not adequate for timing purposes, unless the wrist watch or pocket watch incorporates a stop watch which has been tested for accuracy. Stop watches should be periodically tested for accuracy using the atomic clock (Tel: (303) 499-7111) and this information should be recorded in the investigators notes or elsewhere as per district policy.
2. A pocket calculator for calculating process times, reel speed for continuous cookers, and product formulations.
3. A pocket thermometer for checking the initial temperatures (IT) of the firms products, blanching temperatures and other temperatures critical to the process. A small dial or digital thermometer is acceptable. The thermometer should be accurate and tested for accuracy on a routine basis as per district policy. In an emergency the accuracy of the thermometer can be checked by the investigator by placing the thermometer in an ice bath (0° C/32° F) and in a

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