The food industry continues to be complicated as new food products with unique ingredients are introduced into the marketplace, supply chain interruptions remain a challenge, and the demand for minimally processed foods grows. Ensuring that appropriate food safety parameters are utilized during the manufacture of food products, with the right supporting documentation, is paramount to providing customers with safe and wholesome food.
The Food Safety Modernization Act's (FSMA's) Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food regulation requires that preventive controls for food are validated. Per the regulation, validation "…must include obtaining and evaluating scientific and technical evidence (or, when such evidence is not available or is inadequate, conducting studies) to determine whether the preventive controls, when properly implemented, will effectively control the hazards." Validations for thermal processes are conducted to demonstrate that a specific thermal process can adequately eliminate or reduce the pathogen of concern to a reasonably safe level.