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Arts & Design Validation of Pharmaceutical Processes: Sterile Products, Second Edition, Revised and Expanded

Posted on 2010-04-13




Name:Arts & Design Validation of Pharmaceutical Processes: Sterile Products, Second Edition, Revised and Expanded
ASIN/ISBN:0824793846
Author:Carleton
Publisher:Informa Healthcare (1998)
Language:English
Pages:Hardcover, 856 pages
File size:9.08 Mb
   Arts & Design Validation of Pharmaceutical Processes: Sterile Products, Second Edition, Revised and Expanded


Author: Carleton


Publisher: Informa Healthcare (1998)


Binding: Hardcover, 856 pages


pricer: $229.95


ISBN-10: 0824793846


editorialreviews

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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