Aseptic Pharmaceutical Manufacturing II: Applications for the 1990s
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Summary
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
Chapters include:
Controlled Environments in the Pharmaceutical & Medical Products Industry: A Global View, R. Dabbah
Quality Systems & Total Quality, K. Stephens
Aseptic Processing of Healthcare Products, M. Korczynski & J. Lyda
Validation of Aseptic Processes, V. Kumar & R. Murty
Laboratory Techniques, R. Mehta & R. Murty
Aseptic Production: Radiopharmaceuticals, P. Bremer
Education & Training of Personnel, M. Akers
Predictive Sterility Assurance for Aseptic Processing, C. Sinclair & A. Tallentire
Aseptic Processing of Biopharmaceuticals, N. Lugo
Lyophilization, E. Trappler
Lyophilization Under Barrier Technology, J. Snowman
Aseptic Packaging and Labeling, R. Murty
Barrier Isolation Technology: A Systems Approach, J. Lysfjord, P. Haas, H. Melgaard & I. Pflug
Hydrogen Peroxide Vapor Sterilization: Applications in the Production Environment, L. Edwards & R. Childers
Appendix: USP 23 Chapter 1116: Microbiological Evaluation of Clean Rooms and Other Controlled Environments, United States Pharmacopoeial Convention, Inc.
