Alternative Sterilization Impact on Materials - Highlights and Outcomes

Sterilization is an important aspect of delivering safe medical devices to the market; however, the innovation and implementation of new sterilization modalities are still slow. While new methods exist, they have not been adopted for a variety of reasons, including challenges in material compatibility, the absence of international standardization, the regulatory burden of transitioning products, and the lack of sterilization capacity within the market.

Recognizing these challenges, we are excited to offer a unique opportunity to learn about what was discussed during the International Scientific Exchange (ISE) hosted in March 2024 at the TÜV SÜD headquarters. This event brought industry experts from across the world, including FDA and TÜV SÜD, to exchange ideas on this topic and how to advance it through an interactive webinar.  

This webinar will summarize key topics during the event, including:

• The current landscape of sterilization modalities
• The impact of novel sterilization methods on materials and packaging
• Requirements for testing and documenting new sterilization methods for regulatory submission.
• What’s next: publications and breakout groups focused on material science, biocompatibility, packaging and sterilization.
• How you can take an active role in advancing new methods forward. 

Webinar Agenda:

1. Welcome and Introduction
2. Setting the Stage – Overview of the ISE Conference
   • Highlights of DuPont/Mars Presentations  
3. Alternative Sterilization Modalities  
   • NO2, ClO2, VH2O2, Low Energy Irradiation  
4. Regulatory Insights
   • Extractables & Leachables, BioComp and Packaging
   • Contractor Approvals and Risk Assessments
   • Submission Checklists
5. Safety, Efficacy and Stability
   • Performance Evaluation and Analytical Chemistry
6. Breakout Session Overview and Outcomes
   • Sterilization, Material Science, Packaging
7. Alternative Sterilization Breakout Session Overview and Outcomes
   • VH2O2, ClO2, NO2, Low Energy Irradiation
8. Takeaways, Action Items, and Next Steps

Why Attend?

• Be part of the ongoing discussions led by industry leaders.
• Gain insights into the latest sterilization modalities.
• Access valuable resources that will be generated post-event.

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