PDA Midwest Chapter: Sterilization Conversion
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The PDA Midwest and the Missouri Valley Chapters are pleased to present three speakers for our August 2024 event. With projected Cobalt 60 supply limitations in the future, these presentations will focus on topics related to the medical device sterilization conversions to X-Ray sterilization from Gamma sterilization. The presentations will highlight the opportunities and compare the similarities and differences for converting product from Gamma to X-Ray. In addition, a case study will be presented supporting this sterilization conversion.
Registration for this webinar is free!
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Registration for this webinar is free!
Day 1
11:00am | Opening/Event Overview
11:05am | Sponsor Video
11:07am | Presentation 1 Abstract: Sterilization of healthcare products are well documented with Radiation Technologies (Gamma X-ray and E Beam). Significant guidance is available in published standards, seminars and other publications that make validation of dose, and in most cases easy to document and support. The most widely used historically has been gamma with a smaller percentage of E Beam. As processing capacity needs grow and assurance of supplies of critical products are under pressure, X-ray has become a greater consideration. X-ray has long been an option, but access globally was not always available. As availability is growing, we will discuss why X-ray is a viable alternative or addition to a sterilization portfolio, show how gamma and X-ray compare (similarities and differences), and the basics of how converting from gamma to X-ray is achieved. Speaker: Betty Howard, Senior Radiation Sterilization Manager, Steris Corporation Title: Gamma to X-ray Conversions for sterilization of Healthcare Products
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11:37 | Question and Answer Session for Session 1
11:52am | Presentation 2 Abstract: Case study presentation of a Gamma to X-Ray for sterilization conversion, which discusses testing performed, Dtser, Dmax, activation, dosimetry and Monte Carlo simulation. Speakers: Dr. Samuel Dorey, Principal Scientist, Materials & Irradiations, Product Development, Sartorius and Florent Kuntz, Strategic Development Manager, Aerial Title: X-Ray Sterilization Conversions |
12:12 | Question and Answer Session for Session 2
12:28 | Closing remarks / upcoming events
Featured Presenters
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Samuel Dorey
Sartorius
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Samuel Dorey
Sartorius
Samuel has a strong focus on the radiation application work covering a wide range of applications including radiation effects on SUS for biopharmaceutical processes. Samuel is deeply involved in promoting and facilitating the application of alternative ionizing radiations to gamma. He's the co-chair of the BPSA X-ray-committee, whose objective is to focus on the irradiation sterilization future in the form of X-ray, as increasing capacity constraints impact delivery for the growing single-use market. He is one of the lead authors of the 2021 BPSA technical guide, titled “X-Ray Sterilization of SUS”. He’s also member of the ASTM E61 and of the Panel of Gamma and Electron Irradiation. Additionally, Samuel is part of the Team Nablo initiative to conduct and spread-out specific material compatibility upon the different irradiation modalities. He's one of the lead panelists with the Emerging Technology Team (ETT) at the FDA and BARDA to discuss technology proposal on X-ray sterilization of Single-Use bioprocess equipment for biopharmaceutical manufacturing since 2021. He's one of the authors/co-authors of 20 peer reviewed articles on gamma/X-ray/Ebeam impacts on plastic materials. Samuel is a Principal Scientist, Materials and Irradiations at Sartorius Product Development. He received a PhD in Polymer Science from the Mulhouse University in France.
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Betty Howard
Senior Radiation Sterilization Manager, STERIS
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Betty Howard
STERIS
Ms. Howard has been with STERIS Applied Technologies for more than 17 years and manages/ provides education and scientific guidance to Customers and potential Customers on a global scale for all areas of radiation sterilization. She is a member of industry committees responsible for developing content and guidance in the industry (ex. AAMI Working Groups for Radiation Processing, Sterility Assurance Levels and Materials compatibility). Betty has over 30 years industry experience in healthcare/ diagnostics and pharmaceuticals product applications including Radiation Sterilization ( dose setting, project management, testing) Biotechnology Research, Applications Development and Technical Support related to medical devices, drug discovery, analytic instrumentation, microbiology, biochemistry, sterilization processes and materials compatibility including previous positions with Amersham/GE, PerkinElmer, Illinois Department of Public Health. She holds a BS and MS degree from the University of IL in Biological Sciences and an MBA in Marketing and General Business.
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Florent Kuntz
Strategic Development Manager, Aerial
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