Aseptic Pharmaceutical Manufacturing II

Applications for the 1990s

Michael J. Groves, Ram Murty (Herausgeber)

Buch | Softcover

540 Seiten

2019
CRC Press (Verlag)
978-0-367-40173-3 (ISBN)

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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.

Michael J. Groves, Ram Murty

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.

Erscheinungsdatum	18.09.2019
Verlagsort	London
Sprache	englisch
Maße	152 x 229 mm
Gewicht	1020 g
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Laboratoriumsmedizin
Themenwelt	Technik
ISBN-10	0-367-40173-8 / 0367401738
ISBN-13	978-0-367-40173-3 / 9780367401733
Zustand	Neuware