Descrição
CONTENTS:
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
