Environmental Monitoring: A Comprehensive Handbook, Volume 1 (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 2.42 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


Practical Issues in Designing and Implementing an Environmental Control Program by Jeanne Moldenhauer
(Click here to download >>>Chapter 2)
Compliance Issues for Environmental Monitoring by Jeanne Moldenhauer
Environmental Control Systems used in Parenteral Facilities by Franco De Vecchi
Unidirectional Airflow Devices by Allan Pfitzenmaier
Isolators and Barriers by Jeanne Moldenhauer
Cleanroom Microbiology by Scott Sutton
Particle Counting Applications in the Pharmaceutical Environment by Mark Hallworth
Establishing a Disinfection Program by Vivian F. Denny
Disinfectants by Vivian F. Denny
Cleanroom Supplies by Jeanne Moldenhauer
Practical Aspects of Cleaning, Sanitizing and Disinfecting Rooms and Surfaces by Jeanne Moldenhauer


Masterplan for Microbiological Monitoring by Jeanne Moldenhauer
Validation of HVAC Systems by Jeanne Moldenhauer
Monitoring of Utilities: Compressed Gases by Jeanne Moldenhauer
Validation of Water Systems by Jeanne Moldenhauer
Cleaning/Sanitization Qualification by Jeanne Moldenhauer
Sampling Equipment by Arthur L Vellutato, Jr.
Sample Site Selection by Jeanne Moldenhauer
Selection of Sample Sites using Grid Profiling by Tom O'Connor
Microbiological Risk Analysis by Dilip Ashtekar
Personnel Gowning by Jeanne Moldenhauer
Personnel Monitoring and Certification by Jeanne Moldenhauer
Training Personnel to Collect Environmental Samples by Michele M Conway
Surface Monitoring by Jeanne Moldenhauer
Method Validation by Dawn McIver
Performance Qualification of an Environmental Monitoring Program by Jeanne Moldenhauer
Media Fills/Process Simulations by Jeanne Moldenhauer
Airflow Visualization and Design of Aseptic Procedures by Charles S Levine

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.