Aseptic Pharmaceutical Manufacturing II: Applications for the 1990s, 1st Edition (Paperback) book cover

Aseptic Pharmaceutical Manufacturing II

Applications for the 1990s, 1st Edition

Edited by Michael J. Groves, Ram Murty

CRC Press

520 pages

Purchasing Options:$ = USD
Paperback: 9780367401733
pub: 2019-06-19
Hardback: 9780935184778
pub: 1995-05-31

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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.

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.

About the Editors

Michael J. Groves, Ram Murty

Subject Categories

BISAC Subject Codes/Headings:
MEDICAL / Pharmacology
SCIENCE / Chemistry / General