Strategies for Assessing Unknowns: Simulated Use Testing, Identification, or Pen and Paper Justification?

Extractable compounds with unknown identities are a common problem when conducting a chemical characterization study in support of medical device biocompatibility. With increasing instrument sensitivity, regulatory scrutiny, and the widespread adoption of the Analytical Evaluation Threshold (AET), unknown compounds are being seen in increasing number in many studies. Many manufacturers struggle to address and mitigate the risk of unknowns. This presentation outlines strategies for addressing these unknowns including additional testing, including simulated use testing or identification of the unknowns, as well as a pen and paper justification.