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This volume adds to the wealth of knowledge provided in the previous volumes by addressing several important issues not previously discussed in earlier volumes. It starts with the requirements and establishment of an environmental monitoring program for the quality control microbiology laboratory. There is a chapter introducing the need for environmental trending for smaller companies. Additionally you will find a chapter that describes the types of reports you might want if you are manually trending environmental data.
Other chapters include advice on how to specifically present environmental data to both internal and external stakeholders, details about setting up an identification laboratory at your site followed by a discussion of a newer technology for performing identifications. In recent years that has been an influx of issues with fungal contamination. There are two chapters on dealing with fungal contamination. One provides a wealth of information on the places where fungal contamination originated along with methods to eradicate the contamination. The other chapter introduces a new technology to prevent fungal contamination from occurring. Also included are chapters that provide summary data from a comparison study for the IMD and the SMA prepared by impartial reviewers, not including the vendors of either of the equipment and chapters discussing the need for establishing environmental programs within the compounding pharmacy and the last chapter talks about some of the issues associated with contamination control, specifically for the biotechnology industry.
This book is a welcome addition to any Environmental Monitoring library.
Book written in September, 2011
Table of Contents:
Click here to download >>>Detailed Table of Contents
- Environmental Monitoring of Microbiology Laboratories by Frank
- Data Management â€” Small Size Options by Jeanne Moldenhauer
- Making Sense of Environmental Monitoring Trending Data by Dawn
- Presenting Environmental Monitoring Data to Internal and External
Stakeholders by Kim Van Antwerpen
- Maldi-TOF Method for Identification of Microbial Isolates by David
- Microbial Identification Laboratory in Support of an Environmental
Monitoring Program by Mary J. Griffin
- Environmental Monitoring and the Microbial Control Strategy by Karen
- Fungal Contamination and Disinfection by Jim Polarine and Dan
- Emerging Technology for Fungal Contamination Control by Vladimir
Podipskiy, Sergei Bibikov, Brian Hubka and Daniel Kesonen
- Monitoring of Air in Clean Environments — A Comparative Study with
Instantaneous Microbial Detection by Bengt Ljungqvist and Berit
- Development and Implementation of a Program for Environmental Monitoring
in the Compounding Pharmacy by Jeanne Moldenhauer
- Designing a Contamination Program for Biotech Operations by Jeanne
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.