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Assurance of Sterility for Sensitive Combination Products and Materials New Paradigms to Bring Innovative Healthcare Products to Patients

Langue : Anglais

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

Couverture de l’ouvrage Assurance of Sterility for Sensitive Combination Products and Materials

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.

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

medical device manufacturers and consultants; contract sterilizers; microbiology test houses; regulators; Biomaterials professionals (scientists and engineers); Biomedical engineers; Academics, biomaterials and biomedical researchers
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, Compatibility of Materials Subject to Sterilization.
Stan has been in the medical device and pharmaceutical industries for over 16 years. He is currently Sr Manager RD Process Technology Development at Stryker Neurovascular. Prior to that, he was Manager of Process Development at Abbott Vascular where he was responsible for developing the sterilization process for the bioresorbable scaffold platform. Prior to that, he was Principle Scientist Biopharmaceuticals at ALZA (Johnson and Johnson) where he was involved with the aseptic processing of implantable devices. Stan obtained his PhD in Physical Chemistry and MSc in Colloids and Surfaces at the University of Bristol, England. He obtained his BSc in Chemistry and Biochemistry at the University of British Columbia, Canada.
Joyce Hansen joined Johnson & Johnson as Vice President of J&J Sterility Assurance in 2012. Joyce is responsible for providing strategic vision, leadership and governance for steril¬ity assurance E2E lifecycle management for s
  • 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

Date de parution :

Ouvrage de 266 p.

15x22.8 cm

Disponible chez l'éditeur (délai d'approvisionnement : 14 jours).

193,44 €

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