ABSTRACT

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,

chapter 1|58 pages

THE FREEZE DRYING PROCESS

chapter 2|66 pages

THE FREEZE DRYER AND FREEZE DRYER DESIGN

chapter 3|30 pages

FREEZER DRYER INSTRUMENTATION AND CONTROL

chapter 4|16 pages

REGULATORY ISSUES: A EUROPEAN PERSPECTIVE

chapter 5|16 pages

REGULATORY ISSUES: AN AMERICAN PERSPECTIVE

chapter 6|18 pages

FREEZE DRYER STERILISATION

chapter 7|12 pages

LEAK RATE TESTING

chapter 8|20 pages

INLET FILTER INTEGRITY TESTING

chapter 9|22 pages

FREEZE DRYER VALIDATION

chapter 10|12 pages

CYCLE OPTIMISATION AND PROCESS TRANSFER

chapter 11|18 pages

CFC REPLACEMENT