The second in this series of four books. Provides current, practical techniques that focus on considerations in the preparation and monitoring of aseptic manufacturing, taking into account the national and international requirements, and guidelines concerning the validation of aseptic processing. The guide also includes an excellent Manufacturing and Testing Master Batch Record, and 25 extremely valuable charts, graphs, and figures.
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Documentation and Qualification
Qualification and Training of
Scope of Validation
Example of a Master Batch
Record for the Media Fill Validation
Manufacturing and Testing Record (Master
About the AuthorIntroduction
to Environmental Monitoring in Pharmaceutical Areas
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.
titles wrote by this author :
Monitoring of Pharmaceutical Process Water
Assurance Workbook for Pharmaceutical Manufacturers