As part of the BCF Pharma Extractables & Leachables Online Conference 2021 Annelies Vertommen will share some interesting insights in the protocols and guidelines when alooking at E&L for combination devices.
While extractables/leachables testing on pharmaceutical products is described in USP 1663 and USP 1664, E/L testing on medical devices is defined in ISO 10993-18 (2020). Both regulations share the main concepts, but also show significant differences. Because of that, E&L testing of combination devices faces specific challenges as they are typically a combination of a pharmaceutical product and a medical device.
In this presentation, it is explained how E&L testing on combination devices follows both types of guidelines. In addition, it is demonstrated how E&L testing plays a role in assessing drug-device compatibility.