This comprehensive handbook is intended to provide a framework for the validation
and routine operation of irradiation sterilization processes. It defines methods to assist you in
the interpretation and understanding of ancillary standards and guidelines. It offers practical procedures for the
validation and routine monitoring of your specific radiation sterilization process. Although the scope of the
standards refers to medical devices, the requirements and guidance may be applicable to other health care products.
The guidance presented complies with:
ANSI/AAMI/ISO 11137-1: 2006: Sterilization of health
care products – Radiation – Part 1: Requirements for development, validation and
routine control of a sterilization process for medical devices;
ANSI/AAMI/ISO 11137-2: 2006: Sterilization of health
care products – Radiation – Part 2: Establishing the sterilization dose;
ANSI/AAMI/ISO 11137-3: 2006 – Sterilization of health
care products – Radiation – Part 3: Guidance on Dosimetric aspects.Clearance Sale!
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Table of Contents:
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Introduction
Chapter 1: Rationale for Validating Sterilization
Processes
Chapter 2: Contract Sterilizion
Chapter 3: Process And Equipment
Characterization
Chapter 4: Product Definition
Chapter 5: Microbiological
Considerations
Chapter 6: Sterilization Support Testing
Chapter 7: The
Validation Protocol
Chapter 8: Process Validation
Chapter 9: Final
Report
Chapter 10: Routine Monitoring And
Control
References
Glossary
Appendix
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]