Description
The importance of Extractables and Leachables (E&L) Testing has increased with the growing use of Single-Use Systems. E&L Testing is a regulatory requirement to ensure that leachable impurities from plastic materials used in the processing of a medical product do not interfere with the active pharmaceutical ingredient, thereby ensuring patient safety.
Innovation
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 and potential Leachables based on your process:
Scaling algorithms for short and long contact times
Thousands of combinations and assemblies possible (including CTO and ETO)
Fast retrieval of legacy and calculation data
A reliable source for up-to-date extractables data, substance data and toxicological data
Additional Leachables test in drug product for assessment confirmation and characterization of pot. drug product interaction
Benefits
Expertise: Sartorius has been a thought leader in the field of E&L for more than 25 years.
Flexible Scaling of Extractables: The ExSim enables precise and fast scaling of extractables data even for complex assemblies.
Comprehensive Extractables Profiles: By combining the USP 665 and Sartorius extractables approach, we can generate comprehensive data.
Reduced Validation Costs: Our risk-based approach allows tests to be replaced by Extractables Assessments in certain use cases.
Applications
Single-Use Consumables
Single-Use Assemblies (pre-designed, ETO, CTO)
Intermediate and final Container Closure Systems (CCS)
Services
Process Risk Analysis following BPOG or USP
Extractables Assessment and Safety Evaluation
Extractables Studies according to USP1663, USP 665, BPOG, or Sartorius Approach
Leachables Testing: Screening and Target Analyses
Customized Method Development and Validation
Available Analytical Methods: GC-MS, HS-GC-MS, HPLC-UV, LC-MS, LC-HRMS, ICP-MS/OES, IEC
