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Science/Engineering Validation of Pharmaceutical Processes: Sterile Products, Second Edition

Posted on 2010-03-16




Name:Science/Engineering Validation of Pharmaceutical Processes: Sterile Products, Second Edition
ASIN/ISBN:0824793846
Language:English
File size:27 Mb
Publish Date: November 5, 1998
ISBN: 0824793846
Pages: 856 pages
File Type: PDF
File Size: 27 mb
Other Info: Informa Healthcare
   Science/Engineering Validation of Pharmaceutical Processes: Sterile Products, Second Edition

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Validation of Pharmaceutical Processes: Sterile Products, Second Edition

Featuring contributions from 25 specialists, this book provides a single-source reference on the design of systems, qualification of equipment, calibration and certification. It covers explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. Topics include installation qualification, operational qualification, and change control, F, D, and Z values, steam sterilization-in-place technology and validation, sterilization methods, protocols that allow procedures to be applied directly, obstacles that may be encountered at any stage of the validation program and suggested the solutions.

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