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.