Low-Acid Canned Foods: Thermal Processing and Container Integrity

Low-acid food is defined using pH and water activity, with specified exclusions. The hermetically sealed container and the processing system are central to applicability. A metal can is not the only possible container. Acidified foods have a different rule, so classification must reflect the actual formulation and finished product rather than a convenient commercial category. Part 113.

The scheduled process is established by qualified persons with expert knowledge of thermal processing. It includes the conditions and critical factors necessary for the product, container and processing method. Retort temperature alone is not the full process. Heat distribution, heat penetration and product characteristics are relevant to the scientific basis and control of the operation. Scheduled-process provisions.

The regulation distinguishes processing equipment and systems, including applicable instruments and operational controls. Container examinations address defects capable of affecting the seal. Cooling and post-process handling can affect product integrity even after an adequate thermal cycle. The inspection reference helps explain how equipment, controls and container-handling practices are examined together. FDA inspection guide.

Processing records identify the product, container, equipment and critical operating conditions. A process deviation requires evaluation and appropriate product disposition under the regulation. The affected lot must remain traceable to the deviation and its evaluation. Supervisory review of records is part of control, rather than an administrative exercise detached from the decision to release product. Records and deviations.

Section 108.35 sets registration and process-filing requirements. FDA identifies separate electronic forms for different low-acid processing arrangements. The manufacturer must determine the appropriate form and provide the required product, container and process information. Filing a scheduled process does not transfer operating responsibility to FDA or establish a general approval of every subsequent production batch. FDA electronic filing.

Identify the applicable product and process category, then compare the established scheduled process with actual equipment, instructions and critical-factor records. Review container examination and deviation procedures alongside thermal data. Changes in formulation, container size or operating conditions need competent assessment before assuming an existing process remains adequate. Use the codified rule and inspection reference together. Rule · inspection reference.