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Acidified Foods (21 CFR 114) Checklist
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Verify acidified foods are formulated and processed to achieve and maintain an equilibrium pH of 4.6 or below to control Clostridium botulinum and other pathogens.
21 CFR 114FDAAcidified Foods
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Scheduled Process & Authority
- Is a scheduled process established by a qualified process authority for each acidified product? *
- Is the plant registered and each acidified process filed with FDA (FCE and SID)? *
- Does the scheduled process specify the method and equilibrium pH target of 4.6 or below? *
Operator Training
- Have supervisors of processing and acidification completed a Better Process Control School course? *
- Are operators supervised by a person who has attended a recognized course covering acidification and pH control? *
- Is training documentation on file for processing personnel? *
pH Control
- Is equilibrium pH measured and controlled so the finished equilibrium pH does not exceed 4.6? *
- Is the pH meter standardized before use with buffers bracketing the target pH? *
- Are acidification method controls (batch, direct addition, or blanching) monitored per the scheduled process? *
- Recorded finished-product equilibrium pH
Heat Treatment & Containers
- Is the specified heat treatment applied to destroy vegetative cells of microorganisms of public health significance? *
- Are container closures inspected and results recorded? *
- Is cooling water and post-process handling controlled to prevent recontamination of containers? *
Records & Deviations
- Are pH, heat treatment, and critical factor records maintained for each batch? *
- Are records reviewed and signed by a qualified person and retained at least three years? *
- Is there a documented procedure to hold and evaluate product when a critical factor deviates? *
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