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.
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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.