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Water Activity & pH Control Checklist
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Control product safety through water activity and pH, covering formulation limits, measurement, calibration, and monitoring to prevent pathogen growth and toxin formation.
21 CFR 117FDA Food Code
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Formulation Limits
- Are documented water activity (aw) and pH limits established to control the growth of pathogens? *
- Is the product classified as non-TCS where aw is 0.85 or below or pH is 4.6 or below? *
- Are the critical limits supported by a scientific study or process authority letter? *
- Is a hurdle approach documented where aw and pH are combined to control safety?
Measurement & Instrumentation
- Is water activity measured with a calibrated aw meter under controlled temperature conditions? *
- Is pH measured with a calibrated pH meter or validated method for the product type? *
- Are representative samples taken from each batch or lot for testing? *
- Measured finished product water activity (aw)
Calibration
- Are aw meters verified with saturated salt standards before use? *
- Are pH meters calibrated with certified buffer solutions at the required frequency? *
- Are calibration records maintained and traceable? *
- Measured finished product pH
Monitoring & Corrective Action
- Is each batch monitored against the established aw and pH critical limits before release? *
- Are corrective actions taken and documented when aw or pH is outside the critical limit? *
- Are monitoring and verification records maintained for the required retention period? *
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