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Book ThumbnailEthylene Oxide Sterilization Validation and Routine Operations Handbook (single user digital version)
This comprehensive book provides step-by-step guidance needed to develop and implement a compliant validation program based on current ANSI/AAMI/ISO standards.
by: Anne Booth

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Book ThumbnailPDA Technical Report 48 (TR 48) Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance (single user digital version)
This technical report focuses on the design and operation of moist heat sterilizers, from the development of User Requirements Specifications (URS) through equipment qualification (Installation Qualification (IQ) / Operational Qualification (OQ)) and culminating with ongoing maintenance requirements.

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Book ThumbnailQuality Management in the American Pharmaceutical Industry (single user digital version)
This chapter was listed in the "Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Practice Regulations" published by U.S. Department of Health and Human Services FDA, September 2006 Pharmaceutical CGMP Regulations as Useful Reference Materials.
by: Richard Friedman