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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!
Book written in January, 2015
VOLUME 7Introduction to Cleanroom Design and Operation by Tim Sandle Protecting Cleanrooms from Contamination by Jeanne MoldenhauerCleanroom Gowning and Gowning Certification by Jan EudyCleaning and Disinfecting Cleanrooms by Jim Polarine, Elaine Sartain, and Carol BartnettSteriplex, A New Silver-Based Disinfectant — Non-Corrosive, Non-Toxic, Sporicidal: Disinfectant Efficacy Evaluations by John M. LindsayOzone Gas: Decontamination, Sanitization and Sterilization by Brian G. Hubka and Jeanne MoldenhauerSterilization and Decontamination with Nitrogen Dioxide Gas by David OpieSetting Up an Environmental Monitoring Program for Controlled Aseptic Cleanroom Environments by Ryan Burke and Francis McAteerQuality Risk Management Sampling Plan — A Validation Engineering Perspective by Allan MarinelliPractical Approach on the Efficiency of Microbiological Methods for Environmental Monitoring by Anne-Grit Klees and Reinder HedderichOptimizing Time-to-Results for Environmental Monitoring Applications for Growth-Based Rapid Microbiology Methods by Andrew Sage Real-Time Risk Assessment Control Strategy by Sean TolerEnvironmental Monitoring of Compressed Gases by Tim Cser and Anne ConnorsEnvironmental Monitoring for Sterility Test Isolators by Claire Fritz BrigliaTesting and Verification of Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities by Farhad Memardazeh and Louis DiBerardinisStressed Microbial Populations: Real-World Challenge for Validation of New Applications by Andrew SageReal Time Microbial Analyzer for Water by J.P. Jiang
Click here to download >>>Detailed Table of Contents
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