Header Artwork
Header Artwork


E&L Testing of a combination device: the necessity of understanding the E&L guidelines for pharmaceutical products as well as medical devices

February 18, 2021

3:10 pm CET

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.





Annelies Vertommen

Annelies Vertommen

Scientific Improvement Manager

Annelies Vertommen holds a master’s degree in Biology and a Ph.D. in Bioengineering. She started her career at Nelson Labs as a Study Director for extractables and leachables projects for the pharmaceutical industry. In recent years, her focus changed to chemical characterization studies for the medical device industry. She closely follows all changes in this...