Michael J. Groves (ed.)

Aseptic Pharmaceutical Manufacturing II

Applications for the 1990s
Herausgeber: Groves, Michael J.; Murty, Ram

• Gebundenes Buch

Produktbeschreibung

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.

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Produktdetails

• Verlag: CRC Press
• Seitenzahl: 542
• Erscheinungstermin: 31. Mai 1995
• Englisch
• Abmessung: 240mm x 161mm x 33mm
• Gewicht: 972g
• ISBN-13: 9780935184778
• ISBN-10: 0935184775
• Artikelnr.: 21678758

Autorenporträt

Michael J. Groves, Ram Murty

Inhaltsangabe

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.