The past decade has seen a global emphasis on
environmental monitoring. Regulatory bodies worldwide have all established
standards and guidelines for environmental control. Unfortunately, the
requirements are not equivalent among documents and nations. The Environmental
Monitoring series edited by Jeanne Moldenhauer provides guidance through the ins
and outs of the multitudinous aspects of compliance. They are a must have for
anyone involved in any way with environmental monitoring concerns.
These four volumes with 56 chapters are written by subject matter experts worldwide. Volume 4 focuses on the ins and outs of complying with government regulations circumscribing the sale of parenterals in the world's largest economies. Volume 5 adds chapters on data management, trending and presentation as well as two chapters on fungal contamination and a comparative piece for the IMD and the SMA prepared by impartial reviewers. And finally after a very interesting introduction to microbial monitoring in space, Volume 6 provides a complete overview of how to setup an environmental control program. Volume 7 the first section discusses cleanrooms, ways to prevent contamination. The second section describes various environmental monitoring techniques and methods. The third section explains the changes to standards that occurred for ANSI Standard 29.14 and how this is applicable in pharmaceutical environments and last section talks about new technologies and aides that can be used in evaluating these methods.
There is a wealth of useful information that you can use in establishing, maintaining and updating your environmental monitoring program!
Designing and Validating a Contamination Control Program,
by Sandra A. Lowery and Maureen Mueller
Real-Time Trending of Environmental Monitoring Data
by Austin Kuo, Terrence Shelley and Thomas Burns
The Use of Risk Management in Environmental Monitoring
by Karen Ginsbury
Lean Microbiology Laboratories
by Jeanne Moldenhauer
Observations in Support of Lean Microbial Identification
by David Shelep
Dealing with Contamination: What is the Risk to the Product?
by Jeanne Moldenhauer
Collection Efficiency of Microbiological Impaction Air Samplers
by Bengt Ljungqvist and Berit Reinmuller
Microbiological Excursions in Environmental Monitoring: A Risk-Based Approach in Sterile Production
by Hanna Filipek
Overiew of Recent Warning Letters for Environmental Monitoring
by Jeanne Moldenhauer
Long-Term Microbiological Air Monitoring
by Claudia Scherwing, Jasmin Grigat
and Karl Pflanz
Rapid, Simple and Cost-Efficient Environmental Monitoring of Microorganisms by Fourier-Transform Infrared Spectroscopy
by Mareike Wenning, Gernot Rieser, Siegfried Scherer , Sabine von Brehmer and Grit Schuffenhauer
Microbial Monitoring of the International Space Station by Duane L. Pierson, Douglas J. Botkin, Rebekah J. Bruce, Victoria A. Castro, Melanie J. Smith, Cherie M. Oubre and C. Mark Ott
Environmental Monitoring: A Practical Approach by Tim Sandle
Developing an Environmental Monitoring Program by Barry A. Friedman
Pharma Manufacturing Environmental Monitoring in a Transitioning Paradigm by Steve Douglas
Environmental Monitoring for Non-Sterile Operations by Miriam Rozo
Rapid Microbiological Monitoring in Pharmaceutical Environments by Mark Hallworth
Investigation of a Failure to Meet Endotoxin Specifications in a Water for Injection System by Karen
Zink McCullough
Objectionable Microorganisms in Non Sterile Pharmaceutical Drug Products: Risk Assessment and Origins of Contamination by David Roesti
Neutralization of Disinfectants by Culture Media Used in Environmental Monitoring by Hedderich Reiner and Anne-Grit Klees
Microaerophillics/Anaerobes in Environmental Monitoring of Pharmaceutical Manufacturing by Veronica Marshall and Daniel Eshete
Practical and Business-Based Approaches to Microbial Identifications by David Shelep
The Problem of Burkholderia Cepacia by Jeanne
Moldenhauer
Real Time Clean Room Monitoring for Total and Viable Particles: Biotrak™ Viable Particle Detector by Darrick Niccum and Peter Hairston
Validation of a Rapid System for Environmental Monitoring and Water Testing by Ruth Eden and Roger Brideau
Implementation of a Rapid Microbiological Method to
Monitor and Evaluate the Airborne Pharmaceutical Cleanroom Environment by Peter Noverini
Automation of Environmental Monitoring: Achieving Efficiency and Control by Susan B. Cleary and Parsa Famili
Introduction to Cleanroom Design and Operation by Tim Sandle
Protecting Cleanrooms from Contamination by Jeanne Moldenhauer
Cleanroom Gowning and Gowning Certification by Jan Eudy
Cleaning and Disinfecting Cleanrooms by Jim Polarine, Elaine Sartain, and Carol Bartnett
Steriplex, A New Silver-Based Disinfectant — Non-Corrosive, Non-Toxic, Sporicidal: Disinfectant Efficacy Evaluations by John M. Lindsay
Ozone Gas: Decontamination, Sanitization and Sterilization by Brian G. Hubka and Jeanne Moldenhauer
Sterilization and Decontamination with Nitrogen Dioxide Gas by David Opie
Setting Up an Environmental Monitoring Program for Controlled Aseptic Cleanroom Environments by Ryan Burke and Francis McAteer
Quality Risk Management Sampling Plan — A Validation Engineering Perspective by Allan Marinelli
Practical Approach on the Efficiency of Microbiological Methods for Environmental Monitoring by Anne-Grit Klees and Reinder Hedderich
Optimizing Time-to-Results for Environmental Monitoring Applications for Growth-Based Rapid Microbiology Methods by Andrew Sage
Real-Time Risk Assessment Control Strategy by Sean Toler
Environmental Monitoring of Compressed Gases by Tim Cser and Anne Connors
Environmental Monitoring for Sterility Test Isolators by Claire Fritz Briglia
Testing and Verification of Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities by Farhad Memardazeh and Louis DiBerardinis
Stressed Microbial Populations: Real-World Challenge for Validation of New Applications by Andrew Sage
Real Time Microbial Analyzer for Water by J.P. Jiang
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.
