Having a clear understanding of the chemistry required for regulatory submission is not an easy feat. Chemistry background knowledge is crucial when making decisions regarding study design and preparing a device for submission. With this insight, you can gain more value out of your next extractables/leachables (E/L) tests and avoid over- or under-testing.
It is essential to design an extraction technique tailored to your device. Every device is unique and will require a customized approach. Incorrect testing will not yield proper results and could delay timelines by months. You can only accurately access risks after identifying a device’s materials through appropriate testing.
Sandi Schaible, Senior Director of Analytical Chemistry and Regulatory Toxicology at WuXi AppTec Medical Device Testing, walks through the different extraction types and more in our webinar: “Extraction Techniques: Designing the Right Studies to Get the Answers You Need.”
Schaible starts by diving into the various factors and challenges with:
- Exhaustive extractions
- Exaggerated extractions
- Simulated use extractions
- Leachables
She also discusses the current expectations of different regulatory bodies and provides two case studies using different extraction techniques. Additionally, Schaible explores the updates of ISO 10993-18:2020, while providing insight on how to apply the revision to your testing plan.
In this webinar, you will learn more about the different techniques, the challenges associated with them and much more to help familiarize yourself with the chemistry process and how to determine the method most compatible with your device.
Established in December 2000, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated”.
