Good Pharmaceutical Freeze-Drying Practice: 1st Edition (Hardback) book cover

Good Pharmaceutical Freeze-Drying Practice

1st Edition

Edited by Peter Cameron

CRC Press

320 pages

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Hardback: 9781574910315
pub: 1997-06-30
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eBook (VitalSource) : 9780429171154
pub: 1997-06-30
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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

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology