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Good Pharmaceutical Freeze-Drying Practice

Editat de Peter Cameron
en Limba Engleză Hardback – 30 iun 1997
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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Specificații

ISBN-13: 9781574910315
ISBN-10: 1574910310
Pagini: 320
Dimensiuni: 152 x 229 x 24 mm
Greutate: 0.75 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States

Public țintă

Professional

Cuprins

The Freeze Drying Process. The Freeze Dryer & Freeze Dryer Design. Freeze Dryer Instrumentation & Control. Regulatory Issues: A European Perspective. Regulatory Issues: An American Perspective. Freeze Dryer Sterilization. Leak Rate Testing. Inlet Filter Integrity Testing. Freeze Dryer Validation. Cycle Optimization & Process Transfer. CFC Replacement.

Descriere

This text is devoted to pharmaceutical freeze-drying in all its forms and in all its technological variations. Whether freeze-drying nonsterile tablets or lyophilizing 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.