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OverviewAsceptic 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. Full Product DetailsAuthor: Michael J. Groves , Ram MurtyPublisher: Taylor & Francis Ltd Imprint: CRC Press Weight: 1.020kg ISBN: 9780367401733ISBN 10: 0367401738 Pages: 540 Publication Date: 19 June 2019 Audience: College/higher education , Professional and scholarly , Tertiary & Higher Education , Professional & Vocational Format: Paperback Publisher's Status: Active Availability: In Print ![]() This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsControlled 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.ReviewsAuthor InformationMichael J. Groves, Ram Murty Tab Content 6Author Website:Countries AvailableAll regions |