eBook, ePUB

Assurance of Sterility for Sensitive Combination Products and Materials (eBook, ePUB)

New Paradigms to Bring Innovative Healthcare Products to Patients

Redaktion: Lambert, Byron J.; Bryans, Trabue D.; Hansen, Joyce M.; Lam, Stan

Beschreibung

Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals discusses the medical device industry and existing challenges regarding the exciting new world of sensitive combination products (SCPs) and their terminal sterilization. This book reassesses the current assumptions to assure the patient's best interests are met in the development of increasingly rigorous sterilization methods used to counteract MRSA and other 'super-bugs'. In addition, the book discusses the special challenges faced with implantable medical devices, sterilization requirements and further methods needed for material selection and the design process. This book is unique in taking a holistic, end-to-end approach to sterilization, with a particular focus on materials selection and product design. - Introduces sterilization principles at the material selection and design stages - Addresses the industry need for new sterilization processes for new medical devices and biomaterials - Provides guidance to select the appropriate sterilization technique for newly developed sensitive combination products - Examines forward thinking tactics for matching new developments in material compatibility with possible regulatory and QSR strategies

Technische Details

• Geräte: eReader
• ohne Kopierschutz

Barrierefreiheit

• Text-to-Speech
• E-Mail des Verlags für Barrierefreiheitsfragen: [e-mail]
• E-Mail eines vertrauenswürdigen Mittlers für Barrierefreiheitsfragen: [e-mail]
• Seitennummerierung folgt dem gedruckten Werk
• Mathematische Inhalte in MathML für assistive Technologien
• Text und Medien in logischer Lesereihenfolge angeordnet
• Navigierbarer Index mit direktem Zugriff auf Indexbegriffe
• Navigierbares Inhaltsverzeichnis für direkten Zugriff auf Text und Medien
• Keine Einschränkung der Vorlesefunktionen, außer bei spezifischen Ausnahmen

Autor

Byron has been with Abbott Vascular for 26 years. He is currently in Operations heading Abbott's Sterilization Task Force. He recently worked in Abbott Vascular's R&D as Sr. Associate Research Fellow, Sterilization Science, and as Director of Preclinical Research & Biocompatibility. He previously managed Vascular's sterilization operations, microbiology, chemistry, calibration and reliability engineering groups. His sterilization responsibilities have focused on developing terminal sterilization solutions for sensitive combination devices. He has published numerous journal articles and book chapters and is on the organizing committee of major sterilization related conferences. His Ph.D. is in Chemical Engineering, radiation and polymer science, from the University of Maryland. Byron is convener of ISO TC198 WG2, Radiation Sterilization, co-chair of AAMI WG90, Assurance of Sterility and a member of ISO TC198 WG15, Assurance of Sterility. He formerly co-chaired AAMI WG96, Compatibil

ity of Materials Subject to Sterilization.

Produktdetails

• Verlag: Elsevier Science & Techn.
• Seitenzahl: 266
• Erscheinungstermin: 30. November 2019
• Englisch
• ISBN-13: 9780128131794
• Artikelnr.: 50522308