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
