Live! #80 – Beyond EtO: New EPA Regulations and Sterilization Alternatives

Device Advice by RQM+

This was recorded 18 July 2024. We encourage you to download the presentation slides by ⁠⁠⁠⁠completing the form on this page⁠⁠⁠⁠. Please join us live for future shows for the chance to participate in the chat and ask your own questions! We generally hold one RQM+ Live! panel discussion per month (in addition to more traditional webinars) and you can sign up for these events and more at the ⁠⁠⁠⁠⁠Knowledge Center⁠⁠⁠⁠⁠ or ⁠⁠⁠⁠⁠Events⁠⁠⁠⁠⁠ pages at RQMplus.com.

Thank you for tuning in. 🙏

The recently finalized EPA rule on ethylene oxide (EtO) emissions requires significant changes for sterilization facilities, potentially impacting manufacturers of sterile medical devices.

Listen to our expert panel to understand the implications of these new regulations and discover actionable strategies to explore potential mitigation activities.

In this comprehensive discussion, our experts will cover:

• Impact Assessment: A detailed analysis of the new EPA rule, including how it affects EtO sterilization facilities and manufacturers of sterile medical devices.
• Compliance Strategies: Guidance on softening EtO cycles to support the effort of reducing EtO emissions and ensuring compliance within the 2-3 year timeline.
• Alternative Sterilization Methods: An overview of viable alternatives such as Vaporized Hydrogen Peroxide (VHP), radiation, and more. We will discuss their pros and cons, regulatory requirements, and validation processes.
• Quality and Regulatory Support: Insights into design quality engineering, manufacturing quality engineering, regulatory change impact assessments, and more.
• Industry Perspectives: An examination of feedback from industry stakeholders and how companies are adapting to these changes.

Who Should Listen: This panel discussion is ideal for regulatory affairs professionals, quality engineers, manufacturing leaders, and medical device manufacturers who rely on EtO sterilization or are considering alternative methods.

By listening in, you will gain a clear understanding of the new EtO regulations, learn practical steps to mitigate for compliance-led changes at your sterilization facilities, and explore alternative sterilization methods to ensure your products remain safe and market-ready.

Please complete the form to watch the recording and download the slides.

Panelists:

• Jessica Dreyer – Senior Consultant, RQM+
• Gregory Murdock – Senior Manager, RQM+
• Jon Gimbel, Ph.D. – Vice President of Technical, RQM+ (moderator)

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