DOXPUB 02-0043-PVP-1.0

A process validation protocol for demonstrating the effectiveness and reproducibility of sterilizing vial stoppers and aseptic filling components used in the aspetic filling of Biotin. Sterilization process incorporates Mueller autoclave, model SS-244 . Acceptance criteria includes Thermocouple values, 12-log reduction of bioburden values, non-growth of biological indicators, and review of procedures pertaining to the monitoring, maintenance and operation of the system. Attached forms include a Sterilization Cycle Summary and Thermocouple & Biological lndicator Placement Diagram. Adheres to PDA Technical Monograph No. 1, "Validation of Steam Sterilization Cycles," and USP XXII. The PV Report is available as 02-0043-PVR-1.0.