ABSTRACT

Asceptic Pharmaceutical Manufacturing II explores the sophisticated technology, developments, and applications that allow aseptic processing to approach the sterility levels achieved with terminal sterilization. Written by experts in sterile manufacturing, this book covers aseptic technology, developments, and applications and makes a valuable contribution to understanding the issues involved in aseptic manufacture. Topics include the processing of biopharmaceuticals, lyophilization, personnel training, radiopharmaceuticals, hydrogen peroxide vapor sterilization, regulatory requirements, validation, and quality systems.

chapter 1|9 pages

Introduction

chapter 5|16 pages

Validation of Aseptic Processes

chapter 11|19 pages

Lyophilization

chapter 13|31 pages

Aseptic Packaging and Labeling