July 1st 2020
Extractable and leachable (E&L) testing for finished pharmaceutical products, bioprocess manufacturing systems, and medical devices is currently a subject of intense interest. The majority of the challenges encountered in analytical workflows are related to the highly complex matrices and relatively low analyte evaluation thresholds seen in E&L studies. This paper provide options for executing E&L testing to supporting regulatory submissions. There are multiple compliant routes possible, and the presented workflows and analytical solutions are only one of multiple successful approaches.