Manufacturers - 2

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processing contamination. Container seals or seams should not be handled by employees while they are still wet or warm. The area in which containers are cooled should be protected from employees that may sit on, or place their outer garments, gloves or aprons, on the containers. Observe that practical measures are being taken to protect the containers from external contamination, such as dirt or rainwater, particularly while they are cooling and drying. Observe employees to detect excessive handling of seams or seals, or practices such as wiping seams or seals with porous towels or rags. High velocity air jets which blow the excess water from the containers as they emerge from the cooler have been found to be effective in drying the containers in continuously operating lines. In non-continuous lines, there is an advantage in allowing containers to dry in the retort crates and/or baskets before they are discharged into automatic container handling systems. The effects of rough handling in labeling and casing are considerably minimized when the containers are dry.

Observe that handling systems, including belts and tracks minimize contact with the seam or seal. Ensure that cleaning and sanitizing procedures are in place for these portions of the lines. Tests have shown that significant build-up of spoilage organisms can occur on conveyor belts and runways when they are wet from cooling water even though water of good sanitary condition is employed in the cooler. Consequently, it appears highly desirable that more attention be given to cleaning and sanitizing these portions of the lines regularly in order to hold contamination at a minimum. All tracks, belts and bars which come in contact with the container should be scrubbed with a detergent to remove extraneous materials. After cleaning and subsequent rinse, a sanitizer should be applied freely to all container contact surfaces at the time of each plant clean-up.

Coding of Containers

Container coding is covered under 21CFR 113.60(c) which states that each hermetically sealed container of low-acid processed food must be marked with an identifying code that must be permanently visible to the naked eye. When the container does not permit the code to be embossed or inked, the label may be legibly perforated or otherwise marked, if the label is securely affixed to the product container. The required identification must identify in code the establishment where packed, the product contained therein, the year packed, the day packed, and the period during which packed. The packing period code must be changed with sufficient frequency to enable ready identification of lots during their sale and distribution. Codes may be changed on the basis of one of the following: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers that constitute the batch do not extend over a period of more than one personnel shift, or 8 hrs. If 8 hours is not exceeded a period code is not necessary. However, it should be pointed out to the firm, that having more detail in the code is to their advantage; as in a recall situation less product may have to be recalled. If there is no period code, and 8 hours is exceeded, this can be listed as a FD-483 item, as determined by the investigator.

Accurate and visible code information is imperative for a firm’s recall procedure. During the inspection check the code for legibility, and for other defects, including fractures in the metal at the code due to improper embossing.

FIELD EXAMS/SAMPLE COLLECTIONS

During the inspection the investigator should be alert to container damage from equipment and handling. Examination of finished containers of product at the end of the processing line can provide evidence of container damage due to poor handling practices or faulty equipment. The finished product warehouse stock should be examined to determine if there is evidence of container damage or abnormal containers. Wet cases, rusty containers, and damaged or abnormal containers in the firms storage or morgue areas may indicate problems with abnormal or damaged containers. If problems with container damage or suspect production lots are encountered, conduct a finished product container examination for those lots involved.

Refer to Attachment 13, Sampling Schedule for Canned and Acidified Foods to determine the number of containers to examine and the number of containers to collect for a sample. The containers should be examined for seam defects, dents, abrasions, and other evidence of either rough handling or container manufacturing defects (fractures, cocked bodies, tin plate holes, etc.). Be alert for minor dents and scrapes which could indicate handling abuse, equipment defects, or problems that may elevate and cause punctures. If defects are found, especially those defects which occur repetitively, examine the plant’s container handling system and document the assignable cause. Causative factors may be faulty equipment maintenance, poor equipment design, or inappropriate employee practices.

Abnormal Containers - Two types of abnormalities

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