Environmental Monitoring, Volume 2: Practical Approaches (single user digital version)

Table of Contents:

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1. Rapid Microbiological Monitoring in Pharmaceutical Environments by Mark Hallworth. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 6, Chapter 6 published 2012.)
2. Environmental Monitoring for Non-Sterile Operations by Miriam Rozo. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 6, Chapter 5 published 2012.)
3. Environmental Monitoring for Sterility Test Isolators by Claire Fritz Briglia. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 7, Chapter 14 published 2015.)
4. Presenting Environmental Monitoring Data to Internal and External Stakeholders by Kim Van Antwerpen Sobien. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 5, Chapter 4 published 2011.)
5. Neutralization of Disinfectants by Culture Media used in Environmental Monitoring by Reiner Hedderich and Anne-Grit Klees. (Chapter excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 6, Chapter 9 published 2012.)

About the Authors

Mark Hallworth is the Pharmaceutical Manager for Particle Measuring Systems, Boulder, CO, USA. Mark has managed the design, installation and validation of over 400 environmental monitoring system projects worldwide. He has designed several products specific for pharmaceutical environmental monitoring, including particle counters for explosive and corrosive areas and 21 CFR Part 11 compliant software for batch test and release. He currently lectures for the PDA, ISPE and other international pharmaceutical societies on environmental monitoring and GMP compliance design and validation. Mark recently was awarded the IEST James Mildon award for "significant contributions to the advancement and increase of knowledge in the field of contamination control".

Miriam Rozo holds a J&J Corporate position and is responsible for the Microbiology Laboratory that performs non-release testing of sterile and non-sterile products. She also supports regulatory inspections, investigations and evaluates monitoring programs for the various J&J companies.

Claire Fritz Briglia has over 15 years of experience in pharmaceutical microbiology. She began her career as an R&D scientist at American Sterilizer Company (now STERIS Corporation) developing low temperature decontamination and sterilization systems for both healthcare and life science markets. She then moved into the field to support vapor phase hydrogen peroxide technology for various applications including isolators for aseptic filling and sterility testing, biosafety laboratories as well as medical device sterilization for STERIS Corporation.

In addition to her field experience, she was a product manager where she handled new product development and releases. She currently holds a position at EMD Millipore as a Technology Specialist covering microbiology monitoring applications such as sterility testing, bioburden, environmental monitoring, and rapid. She has presented at many industry conferences over the years (PDA, ISPE, ABSA, AALAS) and continues to speak at customer sites and seminars focusing on pharmaceutical microbiology.

Kim Van Antwerpen Sobien is currently the Microbiology Laboratory Manager at OSO BioPharmaceuticals Manufacturing, LLC in Albuquerque, NM. OsoBio is a contract manufacturing organization (CMO) focusing on biologic and pharmaceutical injectables. She has a B.S. in Microbiology from the University of Wisconsin, La Crosse and a Master of Business degree with an emphasis in global management from the University of Phoenix. Kim is a member of PDA, a Senior Member of ASQ, and is a member on the committee for the PDA 6th Annual Global Conference for Pharmaceutical Microbiology. Kim has held positions of increasing responsibility at OsoBio since 2004, including Environmental Monitoring Coordinator, Lean Six Sigma Black Belt, Production Supervisor, and Microbiology Laboratory Supervisor. She wishes to recognize Mr. James Baker as a developer of the manually derived environmental monitoring trending program presented in this chapter.

Reiner Hedderich, Head of Research and Development at heipha Dr. Müller GmbH, has more than 20 years experience in the field of microbial physiology. He has worked both in basic research and in industry. Reiner holds an undergraduate degree in pharmacy and a PhD in microbiology, both from the Philipps Universität Marburg.

Anne-Grit Klees received an undergraduate degree in biology and in 1992 a PhD degree in microbiology, both from the Philipps Universität Marburg. For the past 17 years, she has gained experience in environmental monitoring (air monitoring and surface monitoring) as a product manager, starting at Biotest in 1994 and moving to heipha Dr. Müller GmbH in 2000.