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
Protocol CD contents:
Validation of HVAC Systems
of Utilities: Compressed Gases
Validation of Water
Performance Qualification of
an Environmental Monitoring Program
Environmental Monitoring and Control System
Typical Procedures Required for an Environmental Control
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.