This book contains pragmatic details on how to accomplish the tasks necessary for a sterility assurance program for steam sterilization processes. Each chapter author is a subject matter expert and has a minimum of 10 years of hands-on experience in the topics discussed.

The authors use this experience to identify practical ways to perform research, development, validation, and production activities associated with steam sterilization.

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Here is a complete collection of practical instructions covering:

• sterilization processes,
• design specifications,
• commissioning,
• installation qualification,
• operational qualification,
• cycle development,
• special considerations for development of cycles for plastic containers,
• performance testing and qualification,
• parametric release,
• on-going monitoring,
• biological indicators,
• handling aberrant sterilization cycles,
• issues related to foreign inspections of sterilization processes,
• and packaging considerations.

The book also contains tremendously useful sample procedures, protocols, and documents to use as templates in your facility.

Table of Contents:

1. How Does Moist Heat Inactivate Microorganisms? - Jeanne Moldenhauer
2. Sterilization Models- Jeanne Moldenhauer
3. Kinetics of the Inactivation of Bacterial Spores in Steam Sterilization - Alfredo Rodriguez
4. International Standards and Requirements - Jeanne Moldenhauer
5. Selecting a Type of Steam Sterilization Process - Jeanne Moldenhauer
6. Purchasing or Building a Steam Sterilizer (Design Specifications) - Jeanne Moldenhauer
7. Factory Acceptance Testing - Jeanne Moldenhauer
8. Installation Testing and Qualification - Jeanne Moldenhauer
9. Steam Quality - What Do I need to Know? - Jeanne Moldenhauer
10. Operational Testing and Qualification - James Voulgarakis and Jeanne Moldenhauer
11. Cycle Development - Michael S. Korczynski and Jeanne Moldenhauer
12. Solution Filled Plastic Vial Steam Sterilization - Diane M. Ippolito
13. Performance Testing and Qualification - Robert Ferer and Jeanne Moldenhauer
14. Standard Operating Procedures - Jeanne Moldenhauer
15. Handling Aberrant Sterilization Cycles - Jeanne Moldenhauer
16. Microbiology Support Systems - Jeanne Moldenhauer
17. Sterility Testing and Sterility-Indicating Test Methods - Jeanne Moldenhauer
18. Developing an Approach for Parametric Release - Thomas J. Berger
19. Monitoring of Sterilizer Performance, Change Control, and Preventative Maintenance - Jeanne Moldenhauer
20. Packaging Considerations for Steam Sterilization - Edward J. Smith
21. Steam Sterilization Support Systems - Jeanne Moldenhauer
22. Can This Product Be Terminally Sterilized? A Guideline to Determine the Capability of a Product to Be Terminally Sterilized - Michelle R. Duncan
23. Product Stability Issues - Jeanne Moldenhauer
Glossary
Appendix 1: The Arrhenius Equation (High-Temperature Acceleration)
Appendix 2: How Does Aseptic Filling Prior to Sterilization Affect the Process?
Appendix 3: Commonly Asked Questions
Index

About the Editor

Jeanne Moldenhauer is a Pharma Consultant with Vectech Pharmaceutical Consultants, Inc. She has over 25 years of experience in sterile process validation, regulatory affairs, and microbiology. She is an interest group leader for microbiology and environmental monitoring at PDA, chair of the Rapid Microbiology User's Group, and a member of the Scientific Advisory Board of PDA.