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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!
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 18.9 MB)
Volume 4 : 2010. Hardcover. 234 pages. ISBN: 1-933722-45-2.
Volume 5 : 2011. Hardcover. 213 pages. ISBN: 1-933722-55-X.
Volume 6 : 2012. Hardcover. 333 pages. ISBN: 1-933722-63-0.
Volume 7 : 2015. Hardcover. 388 pages. ISBN: 1-933722-85-1.
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VOLUME 4
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Designing and Validating a Contamination Control Program,
by Sandra A. Lowery and Maureen MuellerReal-Time Trending of Environmental Monitoring Data
by Austin Kuo, Terrence Shelley and Thomas BurnsThe Use of Risk Management in Environmental Monitoring
by Karen GinsburyLean 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 VOLUME 5
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Environmental Monitoring of Microbiology Laboratories by Frank SettineriData Management — Small Size Options by Jeanne MoldenhauerMaking Sense of Environmental Monitoring Trending Data by Dawn MclverPresenting Environmental Monitoring Data to Internal and External Stakeholders by Kim Van AntwerpenMaldi-TOF Method for Identification of Microbial Isolates by David ShelepMicrobial Identification Laboratory in Support of an Environmental Monitoring Program by Mary J. GriffinEnvironmental Monitoring and the Microbial Control Strategy by Karen GinsburyFungal Contamination and Disinfection by Jim Polarine and Dan KleinEmerging Technology for Fungal Contamination Control by Vladimir Podipskiy, Sergei Bibikov, Brian Hubka and Daniel KesonenMonitoring of Air in Clean Environments — A Comparative Study with Instantaneous Microbial Detection by Bengt Ljungqvist and Berit ReinmullerDevelopment and Implementation of a Program for Environmental Monitoring in the Compounding Pharmacy by Jeanne MoldenhauerDesigning a Contamination Program for Biotech Operations by Jeanne MoldenhauerVOLUME 6
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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 SandleDeveloping an Environmental Monitoring Program by Barry A. FriedmanPharma Manufacturing Environmental Monitoring in a Transitioning Paradigm by Steve DouglasEnvironmental Monitoring for Non-Sterile Operations by Miriam RozoRapid Microbiological Monitoring in Pharmaceutical Environments by Mark HallworthInvestigation of a Failure to Meet Endotoxin Specifications in a Water for Injection System by Karen
Zink McCulloughObjectionable Microorganisms in Non Sterile Pharmaceutical Drug Products: Risk Assessment and Origins of Contamination by David RoestiNeutralization of Disinfectants by Culture Media Used in Environmental Monitoring by Hedderich Reiner and Anne-Grit KleesMicroaerophillics/Anaerobes in Environmental Monitoring of Pharmaceutical Manufacturing by Veronica Marshall and Daniel EshetePractical and Business-Based Approaches to Microbial Identifications by David Shelep The Problem of Burkholderia Cepacia by Jeanne
MoldenhauerReal Time Clean Room Monitoring for Total and Viable Particles: Biotrak™ Viable Particle Detector by Darrick Niccum and Peter HairstonValidation of a Rapid System for Environmental Monitoring and Water Testing by Ruth Eden and Roger BrideauImplementation of a Rapid Microbiological Method to
Monitor and Evaluate the Airborne Pharmaceutical Cleanroom Environment by Peter NoveriniAutomation of Environmental Monitoring: Achieving Efficiency and Control by Susan B. Cleary and Parsa FamiliVOLUME 7
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Introduction to Cleanroom Design and Operation by Tim Sandle Protecting Cleanrooms from Contamination by Jeanne MoldenhauerCleanroom Gowning and Gowning Certification by Jan EudyCleaning and Disinfecting Cleanrooms by Jim Polarine, Elaine Sartain, and Carol BartnettSteriplex, A New Silver-Based Disinfectant — Non-Corrosive, Non-Toxic, Sporicidal: Disinfectant Efficacy Evaluations by John M. LindsayOzone Gas: Decontamination, Sanitization and Sterilization by Brian G. Hubka and Jeanne MoldenhauerSterilization and Decontamination with Nitrogen Dioxide Gas by David OpieSetting Up an Environmental Monitoring Program for Controlled Aseptic Cleanroom Environments by Ryan Burke and Francis McAteerQuality Risk Management Sampling Plan — A Validation Engineering Perspective by Allan MarinelliPractical Approach on the Efficiency of Microbiological Methods for Environmental Monitoring by Anne-Grit Klees and Reinder HedderichOptimizing Time-to-Results for Environmental Monitoring Applications for Growth-Based Rapid Microbiology Methods by Andrew Sage Real-Time Risk Assessment Control Strategy by Sean TolerEnvironmental Monitoring of Compressed Gases by Tim Cser and Anne ConnorsEnvironmental Monitoring for Sterility Test Isolators by Claire Fritz BrigliaTesting and Verification of Ventilation Systems for Biosafety Level 3 (BSL-3) and Animal Biosafety Level 3 (ABSL-3) Facilities by Farhad Memardazeh and Louis DiBerardinisStressed Microbial Populations: Real-World Challenge for Validation of New Applications by Andrew SageReal Time Microbial Analyzer for Water by J.P. Jiang
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.