Volume 8 of the Environmental Monitoring Handbook series is a mixture of new topics and new takes on previously discussed topics. In this volume, you will find information about regulatory/compendial updates, testing methods, risk methods and tools, and routine (and non-routine) monitoring.
This volume is a must have for anyone involved with environmental monitoring!
Table of Contents:
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- Application of ISO 14644 Parts 1 and 2 For Cleanroom Contamination Control by Tim Sandle
- Microbial Monitoring in Cleanrooms: Use of Contamination Recovery Rates (USP<1116>), Real Time Monitoring, and the State of Contamination Control by Claudio Denoya and Gilberto Dalmaso
- Environmental Monitoring for Sterile Compounding by Fran McAteer
- The Changing Expectations for Microbiological Testing of Pharmaceutical Products by Jeanne Moldenhauer
- Particle Counting and Environmental Monitoring by Mark Hallworth
Risk Methods and Tools
- Contamination Control Using a Risk-Based, Automated Cleaning Validation Software System by Susan Cleary and Parsa Famili
Routine Monitoring — And Non-Routine
- A Practical Approach to Investigating Environmental Excursions by Robert Westney
- Environmental Monitoring: Taboos, Investigations, and Impact Analysis by Olivier Chancel
- Environmental Monitoring and Its Impact on Assurance of Sterility by Randy Hutt
- Changing the Paradigm of Cleaning and Disinfection of Cleanrooms by Jeanne Moldenhauer and Brian G. Hubka
- Aging Facilities and Modernizing Aseptic Processes by Michael Hodgkinson
New Technologies and Systems
- Pros and Cons of Using MALDI-TOF MS for Microbiological Identification by Elvira Engelmann and Frank Kugler
- Environmental Monitoring Methods for Production Isolators by Claire Fritz Briglia, Anne Connors, and Tim Cser
About the Editor
Jeanne Moldenhauer, Excellent Pharma Consulting, LLC has more than 25 years of experience in the pharmaceutical industry. She is past chair of the Environmental Monitoring/Microbiology Interest Group of PDA, served on the scientific Advisory Board of PDA, founded the Rapid Microbiology Users Group™ and is a member of ASQ and RAPS. She is the author of numerous journal articles and texts such as Steam Sterilization: A Practitioner's Guide, Laboratory Validation: A Practitioner's Guide and has edited and contributed to many volumes including the successful Environmental Monitoring series, the Contamination Control series with Russel L. Madsen, Rapid Sterility Testing with Margarita Gomez and many other texts.