Process Authority & Process Validation

Process validation consulting for your food production

Both the Food and Drug Administration (FDA) and the Food Safety Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) require that food processes used to control potential public health hazards be validated. The process of validation is the establishment of objective scientific evidence that the process is adequate to prevent, reduce, or eliminate potential public health hazards from the product.

Process validation is critical to food production

Reasons why process validation is important for your food production

Being able to conduct an adequate risk assessment for a process deviation
Reducing the dependence on intensive in-process and finished product testing
Increasing product output and reduced scrap or rework
Lowering complaints and recalls
Building the foundation for process improvements and development of the next generation process

Reasons why process validation is important for your food production

Where product safety cannot be fully verified by meeting a set standard (i.e., milk pasteurization), the process must be validated according to established procedures. When any of the conditions listed below exist, process validation is the only practical means for assuring that processes will consistently produce products that meet their predetermined specifications:

The process adequacy is unknown, or it is suspected that the process is not meeting the intended product safety.
Routine end-product tests have insufficient sensitivity/specificity to verify the desired safety and efficacy of the finished product.
Substantial microbial testing would be required to show that the manufacturing process has produced the desired result or product.
Building the foundation for process improvements and development of the next generation process

Execution

When conducting a validation study, it is important to have appropriate facilities, knowledgeable experts, and recognized protocols. Validation studies can be complicated and are usually costly. IEH has extensive experience and understanding on how to carefully plan and complete a validation study, which includes:

Experience and expert knowledge of USDA and U.S. FDA regulatory requirements
Aseptic fillers and low-acid canned food processing
Application of new and novel extended shelf-life and shelf-stable processing technologies
Thermal treatments including pasteurization and sterilization
Pasteurization of nuts and other low moisture foods
Non-Thermal processing technology included: high pressure processing, pulsed-electric field, pulsed light and UV treatment, irradiation treatments, and the use of sanitizing/sterilizing chemicals
Laboratory facilities to conduct thermal death time (TDT) measurements, microbial detection and enumeration, pathogen growth, survival, or die-off studies, etc.
Substantial microbial testing would be required to show that the manufacturing process has produced the desired result or product.
Building the foundation for process improvements and development of the next generation process

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