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.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 8.09 MB)
Table of Contents:
Click here to download >>>Detailed Table of Contents
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]