Assurance Of Sterility For Sensitive Combination Products And Materials: New Paradigms For The Next Generation Of Medical Devices And Pharmaceuticals by Byron LambertAssurance Of Sterility For Sensitive Combination Products And Materials: New Paradigms For The Next Generation Of Medical Devices And Pharmaceuticals by Byron Lambert

Assurance Of Sterility For Sensitive Combination Products And Materials: New Paradigms For The Next…

byByron LambertEditorStan Lam, Joyce Hansen

Hardcover | June 1, 2018

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Assurance of Sterility for Sensitive Combination Products and Materials: New Paradigms for the Next Generation of Medical Devices and Pharmaceuticalsdiscusses 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
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 operat...
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Title:Assurance Of Sterility For Sensitive Combination Products And Materials: New Paradigms For The Next…Format:HardcoverDimensions:252 pages, 9.41 × 7.24 × 0.98 inPublished:June 1, 2018Publisher:Academic PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0128050829

ISBN - 13:9780128050828

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Table of Contents

1. Introduction/Scope: Sterilization or aseptic processing of single use combination products 2. Sensitive Combination Products; Devices, Pharmaceuticals and Biologics 3. Terminal Sterilization 4. Aseptic Processing 5. Package / Container Closures 6. Review of current practices in the surgical suite 7. Risk to the patient 8. Developing new products 9. Regulatory pathway for sterile labelling 10. Path Forward