Good Pharmaceutical Freeze-Drying Practice

1. Auflage 1997
ISBN: 978-1-57491-031-5
Verlag: CRC Press

Buch, Englisch, 320 Seiten, Format (B × H): 151 mm x 241 mm, Gewicht: 630 g

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.

Zielgruppe

Professional

Autoren/Hrsg.

Cameron, Peter

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizinische Fachgebiete Pharmakologie, Toxikologie

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 Autor(innen)

Peter Cameron