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Food Safety Command Center 16 items

Acidified Foods (21 CFR 114) Checklist

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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