Process Validation
Process Validation
The section provides resources and guidelines to validate thermal processing equipment, conduct validation studies and develop validated cooking instructions that can be used on frozen food packaging, and manage post-lethality contamination by Listeria monocytogenes (Lm) in frozen food facilities.
Process Validation Recommendations
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APPLICATION OF AFFI’S FOOD SAFETY SYMBOL
Follow AFFI’s brand guidelines to apply the recommended “Cook for Safety” symbol.
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CONTROLLING LM IN POST-LETHALITY AREAS
Post-processing or post-lethality areas should be clean and in good sanitary condition so as to prevent post-processing contamination.
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COOKING INSTRUCTIONS ON NRTE FROZEN FOOD PACKAGING
Establish appropriate time-temperature recommendations using challenge studies for each specific product in different domestic cooking ovens and microwaves
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DEVELOPING VALIDATED COOKING INSTRUCTIONS
Develop validated cooking instructions. Apply clear and easy to follow labeling language that is consistent across the industry.
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FINISHED PRODUCT TESTING
Periodic finished product testing (indicator microorganisms) as part of the verification program
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HOW TO VALIDATE A PROCESS CONTROL
All blanchers and thermal processing equipment that are used as the preventive process control step must be validated
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HOW TO VALIDATE YOUR BLANCHER
The use of thermal processing equipment as a preventive process control step should utilize verification systems. Temperatures are monitored and recorded at the beginning of production, at least hourly, or at any time an adjustment is made during thermal processing (batch and continuous). A recording chart should be used to continuously record the (blancher) temperature with an alarm system for immediate notification of deviations. The controls should automatically stop the continuous system belt if the blancher/thermal processor is unable to reach the minimum temperature.
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PREVENTIVE PROCESS CONTROL VALIDATION
If the food safety plan identifies Lm as a hazard that requires a preventive control, then the facility should address this hazard by the application of a preventive process control. One potential method may include a thermal processing step with a 5-log pathogen reduction capability.
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SEPARATION OF RAW AND COOKED AREAS
Areas where blanchers or thermal processers are located or where other ‘log reduction’ processes are performed are considered as raw/uncooked areas and should be fully separated from post lethality/high hygiene areas.
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UTILIZING VERIFICATION TOOLS FOR PROCESS CONTROLS
Thermometers are validated using a certified reference thermometer at least quarterly. The certified thermometer is sent for calibration at least annually.
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VALIDATION OF WATER SYSTEMS IN THE FACILITY
Daily testing of in-line product and processing water samples is highly recommended