April 18–19, 2018Boston Convention & Exhibition CenterBoston, MA

BIOMEDevice Boston 2018 Schedule Viewer

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Extractable and Leachable Chemistry Testing: How to Prepare for the Future in this Time of Transition

Speaker:

Matthew R Jorgensen, PhD (Chemistry and Materials Scientist, Nelson Labs)

Location: Tech Theater, Booth 155

Date: Wednesday, April 18

Time: 1:30pm - 2:15pm

Pass Type: Conference (Paid), Expo (Free) - Get your pass now!

Free Content & Activities: Tech Theater

Vault Recording: TBD

Nelson Labs, LLC

Using extractables and leachables chemistry testing to support biocompatibility assessments and cleaning validations for medical devices is now widely accepted, but it remains a moving target as the approaches develop. A variety of chemical characterization strategies are now available with differing degrees of scientific rigor and diverse regulatory body acceptance. New regulatory draft documents will aide manufacturers in the selection of the application, including the recently published standard ISO 18562 that addresses gas path devices. This presentation will provide a brief overview of the goals of chemical characterization, current approaches, and anticipated changes based on our involvement in industry committees. Attendees will leave informed about how and why we do chemistry testing for medical devices.