Microbial Limit and Bioburden Tests - Validation Approaches and Global Requirements,second Edition

Informationen zum Autor Lucia Clontz Klappentext Now in its second edition! this work guides readers through the various microbiological methods listed in the compendia with easy-to-follow diagrams and approaches to validations of such test methodologies. Zusammenfassung Assists readers in understanding the issues associated with pharmaceutical microbiology and provides them with tools to create microbial contamination control and microbial testing programs for the areas under their responsibility. This work is suitable for those responsible for the microbial quality of products and manufacturing facilities. Inhaltsverzeichnis Microbial Life and Ecology. Microbial Contamination and Control. The USP Microbial Limit Tests. Pharmaceutical Waters. Environmental Monitoring. Bioburden Considerations In Equipment-Cleaning Validation. Method Validation and Media. Suitability Testing. Microbial Quality of Pharmaceutical and Biopharmaceutical Products and Raw Materials. Rapid Testing and Alternative Methods in Microbiology. Biofilms. Handling Aberrant and Out-of-Specification Microbial Data. Index.

Product details

• Authors: Lucia Clontz, Lucia (Diosynth Biotechnology Clontz, Clontz Lucia
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Hardback
• Released: 14.10.2008
• EAN: 9781420053487
• ISBN: 978-1-4200-5348-7
• No. of pages: 342
• Dimensions: 159 mm x 241 mm x 19 mm
• Subjects: Natural sciences, medicine, IT, technology > Biology > Microbiology; Microbiology (non-medical), SCIENCE / Life Sciences / Microbiology, MEDICAL / Microbiology, Medical microbiology & virology, Pharmaceutical technology, Medical microbiology and virology, Pharmaceutical chemistry and technology, TECHNOLOGY & ENGINEERING / Pharmaceutical