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Assurance of Sterility for Sensitive Combination Products and Materials


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Discusses the challenges and potential solutions needed for product design and materials selection in medical device and pharmaceutical manufacturing

Table of Contents

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

About the Author

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 sterility 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 international sterile and aseptic standards settings and internal sterile process knowledge management activities including learning, standards, competencies, 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 radiation (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 industry 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.

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