Date/TimeDate(s) - November 11, 2021 - November 12, 2021
NAMSA invites you to join us at the Extractables and Leachables West Coast Summit 2021 on November 11-12. Throughout this two-day, virtual conference, industry experts will examine the safety, quality and regulatory issues central to the medical device and biotech industries—including the keys to satisfying recent revisions to several applicable USP chapters and the recently revised standards contained in ISO 10993.
NAMSA Education Session
November 12, 2021 | 3:45-4:30 PM PT
Relative Response Factor and Uncertainty Factor Considerations for Non-Linear Detectors Used in Extractables and Leachables
Presented by Nicholas Keyes; Study Director and Principal Analytical Chemist, NAMSA/APS
Description: Recent publications and regulatory guidance documents have emphasized the importance of utilizing an uncertainty factor for adjustment of the Analytical Evaluation Threshold (AET). The uncertainty factor captures the variation in response between different compounds at a given concentration, determined from a database of Relative Response Factors (RRFs).
Meanwhile, quantitation in extractables and leachables is typically carried out using mass spectrometers, supplemented by one or more additional detectors. These detectors have an expected linear dynamic range based upon the inherent chemistry involved. Lacking experimental data for every possible chemical entity that might be observed in an extractables and leachables study, the implied linearity impacts assumptions behind single-point RRF assessments used to generate uncertainty factors, and whether they are sufficiently protective, or even over-protective.
This presentation displays RRF results for ThermoScientific GC/MS and LC/Orbitrap platforms for chemical characterization and compares/contrasts those data with results from comparable instrument platforms performed on Agilent systems from literature. It also showcases a concentration-dependent approach to RRFs, stemming from non-linear responses, and the potential impact on uncertainty factor corrections and quantitation.
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