Assurance of Sterility for Sensitive Combination Products and Materials
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Assurance of Sterility for Sensitive Combination Products and Materials : New Paradigms for the Next Generation of Medical Devices and Pharmaceuticals

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Description

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.
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Product details

  • Hardback | 252 pages
  • 152 x 229mm
  • Academic Press Inc
  • San Diego, United States
  • English
  • 0128050829
  • 9780128050828

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
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About Trabue D Bryans

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 sterile products and the microbial control for non-sterile products across Johnson & Johnson. Additionally, Joyce is responsible for Johnson & Johnson's representation in U.S. and interna--tional sterile and aseptic standards settings and internal sterile process knowledge management activities including learning, standards, competen--cies, and best practices to Johnson & Johnson companies worldwide. Joyce is a member of the Johnson & Johnson Quality & Compliance Leadership Team. Joyce is a recognized industry leader in sterilization practices, and she has over 35 years' experience in sterility assurance. Prior to joining Johnson & Johnson, Joyce was the President and founder of JM Hansen & Associates, a consulting firm that provided manufacturing companies with strategic plans for optimized use of internal sterilization equipment or the use of contract sterilization and laboratory services. She is specialized in the areas of ra--diation (gamma, electron beam and X-ray) and ethylene oxide sterilization. Prior to consulting, Joyce spent six years working for Baxter Healthcare Corporation as Vice President, Sterility Assurance and Sterilization Core Technical Competency Champion. Joyce also held sterilization R&D and/or management positions at Sherwood Davis & Geck, Isomedix, and Becton Dickinson & Company. Joyce holds a B.S. in microbiology from South Dakota State University, and a Masters in Management from the Kellogg Executive Management Program at Northwestern University. Joyce has authored/co-authored more than 20 articles in technical journals and/or chapters in books on sterilization. She is involved in a number of industry activities responsible for developing in--dustry standards for sterility assurance. She previously served as Convenor of the ISO Working Group on Radiation Sterilization and as co-chair of the Association for the Advancement of Medical Instrumentation (AAMI) working groups to develop standards on Radiation Sterilization, SAL, and Microbiological Methods.
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