Extractables & Leachables Testing

<paragraph>The importance of extractables & leachables testing has grown with increased use of single-use systems. Hence, E&L testing is a regulatory requirement to demonstrate that leachable impurities from plastic materials used in the processing of a medical product don’t interfere with the active pharmaceutical ingredient, ensuring patient safety.</paragraph><heading3>Innovation</heading3><paragraph>The Extractables Simulator (ExSim) is an important internal tool that supports our Confidence® Extractables and Leachables services and paves the way for the future of validation. It is a qualified software platform that scales extractables data for Sartorius products and assemblies and predicts the total amount of extractables based on your process:</paragraph><bulletlist><bullet>Scaling algorithms for short and long contact times</bullet><bullet>Thousands of combinations and assemblies possible (incl. CTO and ETO)</bullet><bullet>Fast retrieval of legacy and calculation data</bullet><bullet>A reliable source for up-to-date extractables data, substance data and toxicological data</bullet></bulletlist><heading3>Benefits</heading3><bulletlist><bullet><bold>Expertise</bold>: Sartorius has been a thought leader in the field of E&L for more than 25 years</bullet><bullet><bold>Flexible Scaling of Extractables</bold>: The ExSim enables precise and fast scaling of extractables data even for complex assemblies</bullet><bullet><bold>Comprehensive Extractables Profiles</bold>: Thanks to the combination of the USP <665> and Sartorius extractables approach we can generate such data</bullet><bullet><bold>Reduced Validation Costs</bold>: Our risk-based approach allows tests to be replaced by extractables assessments in certain use cases</bullet></bulletlist><heading3>Applications</heading3><bulletlist><bullet>Single-Use consumables</bullet><bullet>Single-Use assemblies (pre-designed, ETO, CTO)</bullet><bullet>Container closure systems</bullet></bulletlist><heading3>Services</heading3><bulletlist><bullet>Extractables assessments</bullet><bullet>Extractables studies (according to USP <665>, BPOG or Sartorius Approach)</bullet><bullet>Leachables testing</bullet><bullet><bold>Available Analytical Methods</bold>: HPLC-UV, HS-GC-MS, ICP-MS, Ion Chromatography, GC-MS, LC-MS</bullet></bulletlist>