DOXPUB 02-0043-PVR-1.0

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DOXPUB 02-0043-PVR-1.0 English PDF Stopper and Aseptic Filling Component Sterilization Process Validation, Report

standard published 10/01/2004 by Doxpub, Inc.

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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.