This comprehensive book provides step-by-step guidance needed to develop and implement a compliant validation program based on current ANSI/AAMI/ISO standards. It includes discussion of parametric release, reduced Biological Indicators (BI) incubation, support testing and much more.

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Format: PDF (1 file - 8.09 MB)

Table of Contents:
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Introduction (Click here to download >>>Introduction )

Chapter 1: Rationale For Validating Sterilization Processes
Chapter 2: Contract Sterilizers
Chapter 3: Microbiological Considerations
Chapter 4: Sterilization Support Testing
Chapter 5: Process and Product Characterization
Chapter 6: Process Definition (Cycle Development)
Chapter 7: The Validation Protocol
Chapter 8: Outline of the Sterilization Validation Process
Chapter 9: Final Report
Chapter 10: Routine Monitoring And Control
Chapter 11: Parametric Release
References
Glossary
Appendix & Exhibits
Index

About the Author

Anne F. Booth, M.S. is a quality GMP and sterilization specialist with over 24 years of experience in the field of medical device and pharmaceutical manufacturing. She has worked for three medical manufacturers as Microbiology and Sterilization Services Manager/Director and a contract sterilizer as Director of Validation. In each of these positions she provided technical support in the development, validation and management of GMP compliant sterilization programs. Ms. Booth's experience has also included establishing sterilization support testing labs and environmental monitoring programs, developing quality manuals and performing audits, validating cleanrooms and manufacturing processes and recommending cleaning and sterilization programs for reusable devices. She established an independent consulting business, Booth Scientific, Inc., in 1994 which has provided optimal GMP and sterilization programs for more than 50 medical device and pharmaceutical manufacturers.

Ms. Booth has presented at many industry conferences and published three books “Sterilization of Medical Devices” and “Sterilization Validation and Routine Operation Handbook: Ethylene Oxide” and “Sterilization Validation and Routine Operation Handbook: Radiation.” Booth Scientific, Inc. currently offers a two-day intensive sterilization training workshop designed for presentation at a company’s facility.

Ms. Booth holds a MS degree in Cellular Zoology/Biochemistry from the University of Michigan and a BA degree in Biology from Wilson College. She is a member of the American Society of Quality, RAPS, PDA, ISPE and AAMI where she is a member of the EtO sterilization, EtO Residual, Radiation, Microbiological Methods and Reuse standards working groups. She can be reached at 120 Kindy Forest Drive, Hendersonville, NC 28739, 828-891-7485 and by e-mail at [email protected]