Aseptic Pharmaceutical Manufacturing II: Applications for the 1990s / Edition 1

by Michael J. Groves, Ram Murty

Overview

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.

Product Details

ISBN-13:	9780935184778
Publisher:	Taylor & Francis
Publication date:	05/31/1995
Pages:	540
Product dimensions:	6.00(w) x 9.00(h) x (d)

About the Author

Michael J. Groves, Ram Murty

Table of Contents

Controlled Environments in the Pharmaceutical & Medical Products Industry. Quality Systems & Total Quality, K. Stephens. Aseptic Processing of Healthcare Products. Validation of Aseptic Processes. Laboratory Techniques. Aseptic Production: Radiopharmaceuticals. Education & Training of Personnel. Predictive Sterility Assurance for Aseptic Processing. Aseptic Processing of Biopharmaceuticals. Lyophilization. Lyophilization Under Barrier Technology. Aseptic Packaging and Labeling. Barrier Isolation Technology. Hydrogen Peroxide Vapor Sterilization: Applications in the Production Environment. Appendix: USP 23 Chapter 1116: Microbiological Evaluation of Clean Rooms and Other Controlled Environments, United States Pharmacopoeial Convention, Inc.

Editorial Reviews

Explores the technology, developments, and applications of aseptic processing for terminal sterilization, offering how-to information in areas including processing of biopharmaceuticals, lyophilization, manufacture of radiopharmaceuticals, controlled environments, regulatory requirements, and quality systems. Highlights include discussion of hydrogen peroxide vapor sterilization, form-fill-and- seal technology, and international regulatory bodies. Includes b&w photos, and glossaries. For professionals in the development, quality assurance, engineering, and production of pharmaceuticals. Annotation c. Book News, Inc., Portland, OR (booknews.com)

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