ABSTRACT
According to the U.S. FDA (U.S. FDA 1987), process validation involves establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Documented evidence includes a validation protocol of the performance of the UV reactor. The validation protocol comprises the scope of the validation study as well as a detailed description of the procedures, acceptance criteria, and responsibilities. Acceptance criteria are governed by the predetermined specifications of safety and quality attributes, and they should be closely related to the risk of the process steps. For instance, as a result of disease outbreaks across North America associated with the consumption of unpasteurized juices and cider, the U.S. Food and Drug Administration (U.S. FDA) published a juice Hazard Analysis and Critical Control Point (HACCP) regulation designed to improve the safety of juice products (U.S. FDA 2000; U.S. FDA 2001). Under the rule, juice processors are required to produce juice under the HACCP system and achieve a 5-log reduction for the most resistant microorganism of public health significance that is likely to occur in the juice.
