Extractables & Leachables Testing

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.InnovationThe 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:Scaling algorithms for short and long contact timesThousands of combinations and assemblies possible (incl. CTO and ETO)Fast retrieval of legacy and calculation dataA reliable source for up-to-date extractables data, substance data and toxicological dataBenefitsExpertise: Sartorius has been a thought leader in the field of E&L for more than 25 yearsFlexible Scaling of Extractables: The ExSim enables precise and fast scaling of extractables data even for complex assembliesComprehensive Extractables Profiles: Thanks to the combination of the USP <665> and Sartorius extractables approach we can generate such dataReduced Validation Costs: Our risk-based approach allows tests to be replaced by extractables assessments in certain use casesApplicationsSingle-Use consumablesSingle-Use assemblies (pre-designed, ETO, CTO)Container closure systemsServicesExtractables assessmentsExtractables studies (according to USP <665>, BPOG or Sartorius Approach)Leachables testingAvailable Analytical Methods: HPLC-UV, HS-GC-MS, ICP-MS, Ion Chromatography, GC-MS, LC-MS