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Good Pharmaceutical Freeze-Drying Practice

Overview

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...
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Overview

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.
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Editorial Reviews

Booknews
A guide to pharmaceutical freeze-drying in all its forms and technological variations, by practitioners in the industry. Covers freeze dryer process and design, instrumentation and control, validation, GMP requirements, global regulatory concerns, sterilization and testing, cycle optimization, and process transfer and CFC replacement. Includes b&w photos and diagrams. Useful for facility engineers, R&D scientists, validation teams, formulation experts, quality assurance and production professionals, and auditing personnel. Annotation c. by Book News, Inc., Portland, Or.
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Product Details

  • ISBN-13: 9781574910315
  • Publisher: Taylor & Francis
  • Publication date: 6/30/1997
  • Pages: 320
  • Product dimensions: 6.10 (w) x 9.10 (h) x 0.90 (d)

Meet the Author

Peter Cameron
Peter Cameron

PETER CAMERON’s work has appeared in The New Yorker and he is the author of several novels for adults, including Andorra and The City of Your Final Destination. He lives in New York City.

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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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