The “forever chemicals” Per- and polyfluoroalkyl substances (PFAS) are known for their persistence in the environment, leading to potential health issues. Regulatory agencies like the FDA and EPA have set stringent guidelines for PFAS in various products and matrices. However, there is no clear regulatory guidance on PFAS levels present in pharmaceutical products and medical devices, which could compromise product safety. As such, medical device and pharmaceutical manufacturers should be proactive by staying up to date with current and future regulation and develop risk mitigation strategies to avoid costly product recall or delays in approvals.
In this presentation, we will go through the recent regulatory requirements on PFAS in the pharmaceutical and medical device industries. We will also showcase a recently developed novel LC-HRMS based concurrent targeted and untargeted detection of PFAS that could be extracted from pharmaceutical/biopharmaceutical manufacturing components and containers as part of extractables screening. Sensitive detection of multiple PFAS of interest at sub-ppb levels could be obtained with unknown identification of potential PFAS compounds within the same injection.
Learning Objectives:
Upon completion, participant will be able to understand recent regulatory expectations on how PFAS may influence the pharmaceutical industry.
Upon completion, participant will be able to know the common testing techniques for PFAS analysis.
Upon completion, participant will be able to know how to mitigate the risks for PFAS.
