1st Edition

Good Pharmaceutical Freeze-Drying Practice




ISBN 9781574910315
Published June 30, 1997 by CRC Press
320 Pages

USD $180.00

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Book Description

This text is devoted to pharmaceutical freeze-drying in all its forms and in all its technological variations. Whether you freeze-dry nonsterile tablets or you lyophilize injectables, this book covers all the technological and regulatory requirements. Written by a panel of leading practitioners in the pharmaceutical industry -- production experts, regulatory inspectors, technical consultants, and equipment suppliers -- the information is relevant, usable, and timely. Practical, "how to" chapters serve as training aids, and each section stands on its own as a concise, easy-to-access resource for both managers and technicians.

Table of Contents

Chapters include:
o The Freeze Drying Process, K. Murgatroyd
o The Freeze Dryer & Freeze Dryer Design, K. Murgatroyd
o Freeze Dryer Instrumentation & Control, K. Murgatroyd
o Regulatory Issues: A European Perspective, P. Monger
o Regulatory Issues: An American Perspective, L. Butler
o Freeze Dryer Sterilization, K. Kinnarney
o Leak Rate Testing, K. Kinnarney
o Inlet Filter Integrity Testing, P. Cameron
o Freeze Dryer Validation, P. Monger
o Cycle Optimization & Process Transfer, K. Kinnarney
o CFC Replacement, K. Murgatroyd

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