DOXPUB 02-0043-PVR-1.0

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.

Product Details

Edition:

1

Published:

10/01/2004

Number of Pages:

9

File Size:

1 file , 150 KB