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.

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.