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Assurance of Sterility for Sensitive Combination Products and Materials
New Paradigms to Bring Innovative Healthcare Products to Patients
Discusses the challenges and potential solutions needed for product design and materials selection in medical devices and pharmaceutical manufacturing
Byron J. Lambert (Edited by), Stan Lam (Edited by), Joyce M. Hansen (Edited by), Trabue D. Bryans (Edited by)
9780128050828
Hardback, published 30 November 2019
266 pages
22.9 x 15.1 x 2.2 cm, 0.55 kg
Approx.252 pages
1. Introduction: Sterilization or aseptic processing of single use combination products Joyce M. Hansen, and Trabue D. Bryans 2. Sensitive combination products: Devices, pharmaceuticals, and biologics Andrew L. Lewis 3. Terminal sterilization Vu H. Le, Scott Weiss, Brad Lundahl, and Stan Lam 4. Aseptic processing Hal Baseman 5. Package/container closures Thierry Wagner, Jennifer Van Mullekom, Jane Severin, and Michael H. Scholla 6. Review of current practice in preventing health care associated infections Donna Swenson 7. Risk to the patient—Quantifying assurance of sterility Marc L. Speck, Harry Frederick Bushar, James Niederecker, and Byron J. Lambert 8. Developing new products Stan Lam 9. Regulatory pathway for labeling combination products as sterile Trabue D. Bryans, Eamonn Victor Hoxey, and Steven Turtil 10. Path forward Byron J. Lambert, and Joyce M. Hansen
Subject Areas: Materials science [TGM], Biotechnology [TCB], Biomedical engineering [MQW]
