Aseptic Pharmaceutical Manufacturing II

Applications for the 1990s

Michael J. Groves, Ram Murty

$126

Paperback

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English

CRC Press
19 June 2019

Pharmaceutical technology

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.

Edited by: Michael J. Groves, Ram Murty
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 229mm, Width: 152mm,
Weight: 1.020kg
ISBN: 9780367401733
ISBN 10: 0367401738
Pages: 540
Publication Date: 19 June 2019
Audience: College/higher education , Professional and scholarly , Primary , Undergraduate
Format: Paperback
Publisher's Status: Active

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.

Michael J. Groves, Ram Murty