PDA DHI Technical Books

Biological Indicators for Sterilization Processes

Edited by: Margarita Gomez, Jeanne Moldenhauer

This book discusses the basic concepts necessary to the understanding of Biological Indicators and includes the history of biological validation and general principles, the kinetics of microbial inactivation and factors affecting resistance as well as guidance in understanding bacterial endospores due to their high resistance to most inactivation process they are commonly used to challenge the process. Different perspectives on the use of BIs are explained as is validation and monitoring of sterilization processes in the US, Europe and Japan as are the various references and standards available worldwide. This book will be of great interest to laboratory supervisors, regulatory and compliance personnel, validation specialists and professionals engaged in other aspects of pharmaceutical and biopharmaceutical manufacturing.


Table of Contents:
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1. Biological Indicators: Historical Perspective and General Principles — Irving J. Pflug, PhD
2. Bacterial Endospores: Mechanisms that Contribute to their Longevity and Resistance — Peter Setlow, PhD
3. Preparation of Biological Indicators - Russ Nyberg
4. Modeling the Inactivation of Bacterial Spores - Alfredo C. Rodriguez, PhD
5. The Holcomb-Spearman-Karber Method of Analyzing Quantal Assay Microbial Destruction Data - Richard G. Holcomb, PhD and Irving J. Pflug, PhD
6. Influence of Parenteral Solutions and Closure Systems on Biological Indicator Behavior - Thomas J. Berger, PhD, James T. Kiernan and John F. Grillo, PhD
7. Biological Indicators in the Validation of Sterilization Processes: General Overview and European Perspective - Klaus Haberer and Korinna Vreden
8. Japanese Perspective on Biological Indicators - Noboru Kimura, Taku Someya, Yuich Yamagiwa, Mamoru Kokubo, PhD, and Tsuguo Sasaki, PhD
9. Regulatory Expectations for the Use of Biological Indicators - United States Perspective - Jeanne Moldenhauer
10. The Use of Biological Indicators in the Development and Qualification of Moist Heat Sterilization Processes - Mike Sadowski
11. Biological Validation of Radiation Sterilization Processes - Mark A. Seybold
12. Suitability of Biological Indicators for Vaporized Hydrogen Peroxide Decontamination - Volker Sigwarth, Dip Ing.
13. Biological Indicators for Hydrogen Peroxide Gas Plasma Sterilization - Benjamin Fryer and Daniel Smith
14. Biological Indicators for Ethylene Oxide Sterilization - Anne Booth
15. Biological Indicators for Chorine Dioxide Decontamination - Mark A. Czarneski and Paul Lorcheim
16. Bacterial Spore Inactivation by Pressure Assisted Thermal Processing: Challenges in Finding a Suitable Biological Indicator for Process Validation - Wannasawat Ratphitagsanti, Silvia De Lamo-Castellvi, and V.M. Balasubramaniam, PhD
17. Use of Rapid Microbiological Methods for Biological Indicator Testing - Jeanne Moldenhauer and Margarita Gomez, PhD
18. Rapid Readout Biological Indicators - Patrick J. McCormick, PhD, James J. Kaiser, Catherine J. Finocchario, and Deborah L. Shlatz
19. Pharmaceutical Biological Indicator Laboratories and Systems Validation - Jeanne Moldenhauer
20. Contributing Factors to Variability in Biological Indicator Performance - Jeanne Moldenhauer


Review

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"The editors were able to gather extensive information about BIs from experts in this field. Anybody who is involved in BIs (including sterilization processes) will find valuable information. One of the editors herself is an expert in the field of BIs, and both have long experience in the pharmaceutical industry."

"The entire text provides a nice balance between background information and pharmaceutical applications...the editors succeeded in providing an important contribution, and this book can be recommended to anyone involved in the use of BIs."

Mareike Viebahn, PhD
Centocor BV


About the Editors

Margarita Gómez, PhD is a microbiologist with a M.S. and Ph.D. degrees in Food Science from the University of Minnesota. She has more than 20 year involvement with Biological Indicators began as a student in Dr. Irving Pflug’s laboratory at the University of Minnesota and has continued through work as a supplier of Biological Indicators and by providing training and consulting support in the validation of microbial-control processes. She recently joined Ocean Spray Cranberries Inc. as Quality Manager, Corporate Quality. Previously she was Manager of Technical Services at VPCI Inc., where she assisted clients on regulatory, compliance and technical issues in environmental monitoring, microbial control and risk analysis in the pharmaceutical industry. She is a published author.

Jeanne Moldenhauer has over 25 years of experience in sterile process validation, regulatory affairs and microbiology. She is now the Vice President of Excellent Pharma Consulting, Inc. Moldenhauer 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. Moldenhauer is a published author and editor of the above four PDA-DHI books and is the winner of the 2005 PDA/DHI Distinguished Editor/Author Award.


Date of Publication: December 2008
ISBN Number: 1-933722-27-4
Format:
Number of Pages: 536
Binding: Hardcover