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ON-DEMAND WEBINAR

ON-DEMAND WEBINAR

Focus on Fundamentals: Ethylene Oxide and Radiation Sterilization

Published Date: September 7, 2022

With no relief in sight for supply chain issues and sterilization constraints, understanding the options associated with change has become an immediate need in industry.  This 3-day webinar will identify considerations and challenges outlined in regulatory standards to allow for success in an agile environment.  Our topics of focus include navigating Ethylene Oxide & Radiation Sterilization, Packaging, and Biocompatibility/Biosafety changes and addressing the expectations around managing changes.

Day 1: Ethylene Oxide & Radiation Sterilization: Evaluating the Impact of a Change

Abstract: The presentation will cover some case studies addressing the current challenges in a consistently evolving regulation environment. Both environmental considerations and product safety will be covered. Additionally, it will also cover the unavailability of components and material shortages that can lead to lengthy delays or require a revision of the product to continue production. Those revisions require careful consideration with regards to product bioburden terminal sterilization or potential sterilization residues. This presentation will review case studies to provide insight into handling your product or sterilization parameters change.

  • How do component or material changes affect product bioburden?
  • How to evaluate changes to the product or process
  • How changing materials, suppliers, or processes can affect bioburden and sterilization.
  • How Ethylene oxide reduction program can address the lower and challenging residues limits while not compromising the sterility assurance level.
Gregory Grams

Gregory Grams

MS
Sterilization Technical Director, Expert Advisory Services

Gregory is a Sterilization Technical Director with Sterigenics. He is responsible for the development of new cycles, customer validation, and R&D projects. He is a leader in validation, development, and cycle design and improvements. Gregory is an active trainer who enjoys sharing his knowledge with others through formal seminars at trade shows, as well as informal...

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Bryce Telford

Expert Technical Consultant

Bryce Telford is a recognized authority and industry leader on Radiation Sterilization, Bioburden, Microbiology, and Tissue Processing. He has over 13 years of experience working in laboratory functions in research, test design, media formulation, medical device, and tissue industries. Bryce has worked with the Nelson Laboratories representatives to the Association for the Advancement of Medical Instrumentation (AAMI) and the International Organization for Standardization (ISO). He has worked on the updates for ISO 11737-1, and 11737-2. He is currently the document owner of multiple Nelson Laboratories Standard Testing Protocols (STP), Work Instructions (WI) and Standard Works (SW). He acts as one of the Nelson Laboratories Bioburden and Radiation Sterilization subject matter experts and is a master trainer for new ISO Bioburden and Radiation Study Directors.

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