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

ISBN-13: 9780128050828 / Angielski / Twarda / 2019 / 266 str.

Byron Lambert; Stan Lam; Joyce Hansen

Opis

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 the difficult challenge it faces with regard to developments in the exciting new world of sensitive combination products (SCPs) and the terminal sterilization of these devices. Traditional sterilization technologies, validation methodologies, and regulatory frameworks that have worked well for more than three decades do not meet the current challenges for these new classes of products. This book reassesses the current assumptions, the logic, and the regulatory paradigms 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

Spis treści

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

O autorze

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 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. Ms. Bryans has over 30 years' experience in the medical device and biopharm industries. She has a B.S. in Microbiology from University of Georgia and M(ASCP) certification in Microbiology from the Medical College of Georgia. She was VP & Gen. Mgr. of the Atlanta division of ViroMed and then WuXi AppTec, and is now a consultant at BryKor LLC, specializing in strategic approaches for regulations and testing associated with the sterilization sciences.
She is Convener of the ISO Microbiological Methods Working Group, an Expert Member of the ISO Assurance of Sterility Working Group and is on the AAMI Standards Board. She previously served on the AAMI Committee on Standards Strategy and Board of Directors, as well as Co-chair of the AAMI Microbiological Methods committee, Sterility Assurance committee and Radiation Sterilization committee. She also served on the AATB Standards Committee and Scientific and Technical Advisory Committee.