Missed our webinar with iuvo BioScience - Chemical Characterization Requirements: ISO 10993-18 and Extractables & Leachables Requirements?
Good news: you can now download the slides and view the recording.
The webinar explained the standards for both industries, discussed the testing methodologies required, and provided some case study experience from an E&L perspective. Participants learned:
- Basic terminology used in these studies, the difference between an extractable and a leachable, and how these terms are used in the medical device and pharmaceutical industries
- The chemical characterization requirements for both the medical device industry and pharmaceutical industry, and the implications for combination products
- Basic parameters for when these studies are required and how they are set up, including some things to look out for when designing a study
- Some real world case study experience from extractables and leachables testing
Here's a preview of the 42-slide presentation: