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.
- Edition:
- 1
- Published:
- 10/01/2004
- Number of Pages:
- 9
- File Size:
- 1 file , 140 KB
Reviews
There are no reviews yet.