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.
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Format: PDF (1 file - 13.1
MB)
Paper version is not available.
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
Literature
Addresses of
Manufacturers
Biography
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