Our CEO Carla Landolfi held a lecture on Extractables and Leachables during the Vonlanthen’s 2023 event, titled “E&L toxicological risk assessment – approached for E&L risk assessment in medical area”.
During her lecture, she touched upon some pivotal subjects, such as:
– Regulatory landscape both for medical devices and pharmaceutical products;
– The relevance in defining the correct SCT, based on the exposure and
– Toxicological risk assessment procedures for known and unknown compounds and related uncertainties.
Evaluating Extractables and Leachables (E&L) is of paramount importance in the medical field. This rigorous risk assessment process ensures the safety and reliability of medical devices and pharmaceutical products. By identifying and analyzing substances that can leach into or be extracted from these products, healthcare professionals can guarantee that patients receive only the highest quality treatments without any potential risks associated with unwanted chemical interactions.