Good Pharmaceutical Freeze-Drying Practice

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.

Inhaltsverzeichnis

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.

Über den Autor / die Autorin

Peter Cameron

Produktdetails

• Mitarbeit: Peter Cameron (Herausgeber), Cameron Peter (Herausgeber)
• Verlag: Taylor and Francis
• Sprache: Englisch
• Produktform: Fester Einband
• Erschienen: 30.06.1997
• EAN: 9781574910315
• ISBN: 978-1-57491-031-5
• Seiten: 320
• Gewicht: 750 g
• Themen: Naturwissenschaften, Medizin, Informatik, Technik > Medizin > Nichtklinische Fächer; Sozialwissenschaften, Recht,Wirtschaft > Wirtschaft > Einzelne Wirtschaftszweige, Branchen; HEALTH & FITNESS / General, MEDICAL / Pharmacology, Popular medicine & health, Pharmacology, Popular medicine and health