Extractables and Leachables USA 2021

Dr. Dujuan Lu, Manager for Extractables & Leachables (E&L) at SGS will be presenting 'Analytical Considerations in Extractable and Leachable Studies of Medical Devices per ISO 10993-18:2020' on Thursday July 1 at 2:00 pm.

About the Conference

Extractables & Leachables USA 2021, will be held virtually from June 29 to July 1. The conference will focus on "Adapting and Thriving in the Face of Change: Navigating the Challenges of an Evolving Landscape and Preparing for the Future of E&L."

The conference is the key place in the industry for technical discussions around testing methodologies and packaging systems in the life science industry.

About Our Presentation

Dr. Dujuan Lu, Manager for Extractables & Leachables at SGS will be presenting 'Analytical Considerations in Extractable and Leachable Studies of Medical Devices per ISO 10993-18:2020' on Thursday July 1 at 2:00 pm.

This presentation will focus on the analytical considerations of medical device E&L studies per the new ISO 10993-18 chapter. Topics to be covered will include:

1. Understand the analytical testing requirements per the new ISO 10993-18.
2. How to design an extractable study of medical devices in terms of solvent selection, extraction conditions, setting the suitable analytical evaluation threshold (AET), etc.
3. Analytical case studies per common regulatory deficiency points on medical device E&L studies.

For more information, please contact:

Aurelia Resines
Global Head of Marketing
t: +41 22 739 91 11