Extractables and Leachables testing is an important component of regulatory medical device testing. In this presentation we will cover the design, implementation, and interpretation of an E&L study. Actual data is presented from an example biopharmaceutical device along with rational describing choices for study design, instrument selection, and identification/quantitation strategies. Additionally, this presentation emphasizes the benefits of combining chemometric identification schemes with high resolution mass spectrometry and the impact that these strategies have on reducing the total number of unknown species.
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