Environmental Monitoring: A Comprehensive Handbook, Volume 2 (single user digital version)

Dec 2014
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PDF Single user
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Environmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application of these procedures is for sterile products manufactured by aseptic processing, while less stringent procedures may be appropriately employed for terminally sterilized products, and even less stringent procedures for non-sterile products.

Environmental Monitoring, written by authors with extensive experience in environmental monitoring and should provide practical guidance on how to establish and maintain a system that will be meaningful, manageable and defendable.

Winner, 2010 and 2005 PDA/DHI Technical Book Distinguished Editor/Author Award

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 8.27 MB)

Book written in July 2005

Bundle Vol. 4, 5, 6, & 7
Bundle Vol. 1, 2 & 3
Volume 1
Volume 2
Volume 3
Volume 4
Volume 5
Volume 6
Volume 7
Volume 8
Protocol CD in PDF format

Table of Contents

Table of Contents:
Click here to download >>> Detailed Table of Contents


Establishing Ongoing Monitoring, Surveillance and Evaluation Programs by Jeanne Moldenhauer
(Click here to download >>>Chapter 1)
Establishing Alert and Action Levels: The Analysis of Environmental Monitoring Data by Tom Genova
Trending Data by Jim Radigan
Reporting Data by Jeanne Moldenhauer
Using Environmental Monitoring Data to Support Steam Sterilization Process Validation by Jeanne Moldenhauer and Michael S Korczynski
Environmental Monitoring for Sterilization Process Development by Anne Booth
Challenges with the Identification of Organisms by Mike Waddington
Environmental Monitoring Investigations by Karen Ginsbury
Change Control and Preventative Maintenance by Jeanne Moldenhauer
Environmental Monitoring and Control System Assessments Typical Procedures Required for an Environmental Control Program by Jeanne Moldenhauer
What is Required Following Remodeling by Jeanne Moldenhauer
Automating an Environmental Control Program by Jeanne Moldenhauer
Environmental Impact on Media Fills by John Lindsay
Environmental Monitoring in Non-Sterile Product Manufacturing by Anthony M Cundell


Introduction to Rapid Microbial Methods for Environmental Monitoring by Jeanne Moldenhauer
Rapid Methods for Water Monitoring by Jeanne Moldenhauer
Environmental Monitoring Using the Scan RDI Polym'Air by Jeanne Moldenhauer and Pascal Yvon
Rapid Environmental Monitoring Using the Growth Direct Test by Don Strauss et al
Identification Systems by Jeanne Moldenhauer and Scott Sutton
Pall System by Lucia Ceresa


Glossary by Jeanne Moldenhauer
Start-Up Limits for Environmental Monitoring by Jeanne Moldenhauer
Implementation and Automation of the LIMS System by George M Levinson
Acquisition and Implementation of an Environmental Monitoring Software Program by Susan Cleary
Automating, Managing and Tracking Investigations by Jeanne Moldenhauer and James Radigan
Comparative Mold and Yeast Recovery Analysis by V Marshall, S Poulson-Cook, J Moldenhauer
HEPA Mobile Storage Carts by Seth Pyers

About the Authors

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.