Microbiological Monitoring of Pharmaceutical Process Water (single user digital version)

Dec 2002
PDA Item Number
PDF Single user
Member Price
Nonmember Price
Government Price

Following a discussion of the regulations to be followed in the microbiological control of water processing and distribution systems, this work focuses on practical aspects in the pharmaceutical environment and gives advice on the methodology to be used, e.g., for sampling, the selection of nutrient media, incubation conditions, and identification of contaminants. It also describes trend analysis strategies and quality assurance to help you ensure consistent validation of water processing and distribution systems. The practices here were developed in a pharmaceutical manufacturing facility that produces drugs for parenteral use. The design, installation, and operation of a system to produce Purified Water and Water for Injection is presented and the practical aspects of microbiological monitoring is discussed.

Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file - 23.6 MB)

Paper version is not available.

Table of Contents

Table of Contents:

I. Intention of this Book
II. Introduction
III. Purified Water and Water for Injection Systems
IV. Requirements of Water Systems and Validation
V. SOP: Microbiological Monitoring Plan
VI. SOP: Validation of a Process Water Distribution System
VII. Trend Data Analysis of Microbiological Monitoring
VIII. Method Validation
IX. Microbiological Leak Test of Supply Pipes
X. References
XI. Further Reading

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.