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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
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.
Table of Contents:
Click here to download >>> Detailed Table of Contents
PART 1 - GENERAL
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
Devices by Allan Pfitzenmaier
Isolators and Barriers by Jeanne
Cleanroom Microbiology by Scott Sutton
Counting Applications in the Pharmaceutical Environment by Mark
Establishing a Disinfection Program by Vivian F.
Disinfectants by Vivian F. Denny
Cleanroom Supplies by
Practical Aspects of Cleaning, Sanitizing and
Disinfecting Rooms and Surfaces by Jeanne Moldenhauer
PART 2 -
VALIDATION AND QUALIFICATION
Masterplan for Microbiological
Monitoring by Jeanne Moldenhauer
Validation of HVAC Systems by
Monitoring of Utilities: Compressed Gases by
Validation of Water Systems by Jeanne
Cleaning/Sanitization Qualification by Jeanne
Sampling Equipment by Arthur L Vellutato,
Sample Site Selection by Jeanne Moldenhauer
Sample Sites using Grid Profiling by Tom O'Connor
Analysis by Dilip Ashtekar
Personnel Gowning by Jeanne
Personnel Monitoring and Certification by Jeanne
Training Personnel to Collect Environmental Samples by
Michele M Conway
Surface Monitoring by Jeanne
Method Validation by Dawn McIver
Qualification of an Environmental Monitoring Program by Jeanne
Media Fills/Process Simulations by Jeanne
Airflow Visualization and Design of Aseptic Procedures by
Charles S Levine
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.