Environmental Monitoring: A Comprehensive Handbook, Volume 6 (single user digital version)

Table of Contents:

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Preface

1. Microbial Monitoring of the International Space Station by Duane L. Pierson, Douglas J. Botkin, Rebekah J. Bruce, Victoria A. Castro, Melanie J. Smith, Cherie M. Oubre and C. Mark Ott
2. Environmental Monitoring: A Practical Approach by Tim Sandle
3. Developing an Environmental Monitoring Program by Barry A. Friedman
4. Pharma Manufacturing Environmental Monitoring in a Transitioning Paradigm by Steve Douglas
5. Environmental Monitoring for Non-Sterile Operations by Miriam Rozo
6. Rapid Microbiological Monitoring in Pharmaceutical Environments by Mark Hallworth
7. Investigation of a Failure to Meet Endotoxin Specifications in a Water for Injection System by Karen Zink McCullough
8. Objectionable Microorganisms in Non Sterile Pharmaceutical Drug Products: Risk Assessment and Origins of Contamination by David Roesti
9. Neutralization of Disinfectants by Culture Media Used in Environmental Monitoring by Reiner Hedderich and Anne-Grit Klees
10. Microaerophillics/Anaerobes in Environmental Monitoring of Pharmaceutical Manufacturing by Veronica Marshall and Daniel Eshete
11. Practical and Business-Based Approaches to Microbial Identifications by David Shelep
12. The Problem of Burkholderia Cepacia by Jeanne Moldenhauer
13. Real Time Clean Room Monitoring for Total and Viable Particles: Biotrakâ„¢ Viable Particle Detector by Darrick Niccum and Peter Hairston
14. Validation of a Rapid System for Environmental Monitoring and Water Testing by Ruth Eden and Roger Brideau
15. Implementation of a Rapid Microbiological Method to Monitor and Evaluate the Airborne Pharmaceutical Cleanroom Environment by Peter Noverini
16. Automation of Environmental Monitoring: Achieving Efficiency and Control by Susan B. Cleary and Parsa Famili

Appendix
Index

About the Editor

Jeanne Moldenhauer, Excellent Pharma Consulting, has nearly 30 years of experience in the pharmaceutical industry. She chairs the PDA Environmental Monitoring/Microbiology Interest Group, serves on the PDA Scientific Advisory Board, founded the Rapid Microbiology User`s Group TM, and is a member of ASQ and RAPS. She is the author of Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2; Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection and the Editor of Steam Sterilization: A Practitioner`s Guide; Laboratory Validation: A Practitioner`s Guide; Systems Based Inspections for Pharmaceutical Manufacturers and Thermal Validation in Moist Heat Sterilization among numerous other recent publications. She is the winner of the 2010 and 2005 PDA/DHI Distinguished Editor/Author Award.