ABSTRACT
The basic requirement for validating manufacturing processes, of which sterilization is one, is defined in the Food and Drug Administration's Quality System Regulation 21 CFR Part 820, the process shall be validated with a high degree of assurance and approved according to established procedures. The validation activities and results, including the date and signature of the individual approving the validation and where appropriate the major equipment validated, shall be documented."The entire sterilization system consists of multiple components, all of which require application of quality procedures, operator training, continuous monitoring, and failure investigation when necessary. In addition, the ISO 9000 series designates certain processes used in manufacturing as "special" in that the results cannot be fully verified by subsequent inspection and testing of the product. Sterilization is one of these special processes, and for this reason, it requires validation before use. The performance of the process also needs to be monitored routinely.
