Introduction to Environmental Monitoring in Pharmaceutical Areas (single user digital version)

Dec 2001
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Dr. Michael Jahnke, Head of Microbiology at Pharma Hameln GmbH, introduces you to the subject of environmental monitoring of pharmaceutical areas.

Major topics covered include: Cleanrooms including discussions of zones, classifications, assignment of production rooms; Air-handling systems; Causes of contamination with details about HAACP and risk analysis; Microbiological monitoring of rooms, personnel, and technical installations; How to use various methods to determine causes of contamination; Standard operating procedures for monitoring and counting particles; Aids and methods for identification of unknown samples; Nutrient media and incubation conditions; References, readings, lists of manufacturers, and other useful appendix material. Numerous useful charts, tables, and figures are included.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 13.1 MB)

Paper version is not available.

Table of Contents

Table of Contents:

Chapter 1 - Introduction
Chapter 2 - Clean Rooms
Chapter 3 - Air Handling Systems
Chapter 4 - Causes of Contamination
Chapter 5 - Microbiological Monitoring of Rooms, Personnel, and Technical Installations
Chapter 6 - Methods (How To…)
Chapter 7 - Standard Operating Procedures
Chapter 8 - Identification
Chapter 9 - Nutrient Media and Incubation Conditions
Addresses of Manufacturers

About the Authors

About the Author

Dr. Michael Jahnke
studied biology at the universities of Bielefeld and Hanover, Germany. He obtained his Ph.D. from the Institute of Microbiology at the University of Hanover. From 1990-1994, he was Head of the Biology Department at IBR Forschungs GmbH and is now Head of the Quality Control/ Microbiology Department at Pharma Hameln Gmbh. In this position, he is responsible for hygiene aspects, microbiological quality control, process validation, and risk analysis strategies. He is a member of the American Society for Microbiology (ASM), the Parenteral Society, the Deutsche Gesellschaft fur Hygiene und Mikrobiologie (DGHM), and he serves on the Editorial Board of European Journal of Parenteral Sciences of the Parenteral Society.

Other titles wrote by this author :

  • Media Fill Validation Environmental Monitoring During Aseptic Processing
  • Microbiological Monitoring of Pharmaceutical Process Water
  • Quality Assurance Workbook for Pharmaceutical Manufacturers