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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.
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.
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- ID: 9780935184778
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