This is volume 7 of the Environmental Monitoring Handbook series. Each volume of this series discusses different aspects of environmental monitoring. One of the first topics discussed in this volume is the topic of cleanrooms and ways to prevent contamination. Subject matter experts Dr. Tim Sandle, Jan Eudy, Jim Polarine, John Lindsay and others describe new and/or better ways to do things.
The second section of the book describes various environmental monitoring techniques and methods and includes informative chapters from Ryan Burke, Allan Marinelli, Dr. Andrew Sage, Tim Cser, Sean Toler, Claire Fritz Briglia and others.
The third section of the book deals with changes to standards. Memarzadeh and DeBerandinis explain the changes that occurred for ANSI Standard 29.14 and how this is applicable in pharmaceutical environments and the last section of this volume talks about new technologies and aids that can be used in evaluating these methods with chapters from Dr. Sage and Dr. JP Jiang.
There is a wealth of useful information that you can use in establishing, maintaining and updating your environmental monitoring program!
Introduction to Cleanroom Design and Operation by Tim Sandle
Protecting Cleanrooms from Contamination by Jeanne Moldenhauer
Cleanroom Gowning and Gowning Certification by Jan Eudy
Cleaning and Disinfecting Cleanrooms by Jim Polarine, Elaine Sartain, and Carol Bartnett
Steriplex, A New Silver-Based Disinfectant Non-Corrosive, Non-Toxic, Sporicidal: Disinfectant Efficacy Evaluations by John M. Lindsay
Ozone Gas: Decontamination, Sanitization and Sterilization by Brian G. Hubka and Jeanne Moldenhauer
Sterilization and Decontamination with Nitrogen Dioxide Gas by David Opie
Setting Up an Environmental Monitoring Program for Controlled Aseptic Cleanroom Environments by Ryan Burke and Francis McAteer
Quality Risk Management Sampling Plan A Validation Engineering Perspective by Allan Marinelli
Practical Approach on the Efficiency of Microbiological Methods for Environmental Monitoring by Anne-Grit Klees and Reinder Hedderich
Optimizing Time-to-Results for Environmental Monitoring Applications for Growth-Based Rapid Microbiology Methods by Andrew Sage
Real-Time Risk Assessment Control Strategy by Sean Toler
Environmental Monitoring of Compressed Gases by Tim Cser and Anne Connors
Environmental Monitoring for Sterility Test Isolators by Claire Fritz Briglia
Testing and Verification of Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities by Farhad Memardazeh and Louis DiBerardinis
Stressed Microbial Populations: Real-World Challenge for Validation of New Applications by Andrew Sage
Real Time Microbial Analyzer for Water by J.P. Jiang