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 Two
books by Dr. Michael Jahnke (Pharma Hameln) have just been published at Davis-Horwood-International
Publishing
providing comprehensive information about microbiological and
environmental monitoring in the pharmaceutical industry. This book is a
MUST for everyone working in this area.
Aseptic
Processing: The Importance of Microbiology and Environmental Monitoring in
Media Fill Validation
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. Topics include: Risk analysis, HAACP, Documentation
and qualification; Qualification and training of personnel; Scope of
validation; Overall requirements; Release requirements; Documentation;
Authorization. The guide also includes an excellent Manufacturing and
Testing Master Batch Record, and 25 extremely valuable charts, graphs, and
figures. 80 pages.
Aseptic
Processing: The Importance of Microbiology and Environmental Monitoring in
Media Fill Validation Introduction to the Environmental Monitoring of
Pharmaceutical Areas
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. 80 pages.
For
details and ordering information please click here
Dr Michael Jahnke is
co-author of the book Pharmaceutical Quality Systems, publisheb by
Interpharm Press USA. The subject of his article is HACCP. To
read more, please click here.
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