A process validation report that describes the Conclusions and Recommendations of a successfully completed PV Protocol for sterilizing vial stoppers and aseptic filling components used in the aspetic filling of Biotin.Includes Results & Analysis sections for each data collection form identified in the PV Protocol, 02-0043-PVP-1.0.Adheres to PDA Technical Monograph No. 1, “Validation of Steam Sterilization Cycles,” and USP XXII.
- Edition:
- 1
- Published:
- 10/01/2004
- Number of Pages:
- 9
- File Size:
- 1 file , 150 KB
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