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Validation of Pharmaceutical Processes: Sterile Products, Second Edition

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Details the design of systems, qualification of equipment, callibration and certification, and explicit procedures for the validation of systems required in the preparation of aseptic and nonaseptic pharmaceutical products. The book contains new chapters on installation qualification, operational qualification, and change control; F, D and Z values; steam-sterilization-in-place technology and validation; and disinfectants.

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Validation of Pharmaceutical Processes: Sterile Products, Second Edition 1998, CRC Press, New York, NY

ISBN-13: 9780824793845

2nd Rev and Expanded edition

Hardcover