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.
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:
- Scaling algorithms for short and long contact times
- Thousands of combinations and assemblies possible (incl. CTO and ETO)
- Fast retrieval of legacy and calculation data
- A reliable source for up-to-date extractables data, substance data and toxicological data
- 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: Thanks to the combination of the USP <665> and Sartorius extractables approach we can generate such data
- Reduced Validation Costs: Our risk-based approach allows tests to be replaced by extractables assessments in certain use cases
- Single-Use consumables
- Single-Use assemblies (pre-designed, ETO, CTO)
- Container closure systems
- Extractables assessments
- Extractables studies (according to USP <665>, BPOG or Sartorius Approach)
- Leachables testing
- Available Analytical Methods: HPLC-UV, HS-GC-MS, ICP-MS, Ion Chromatography, GC-MS, LC-MS
Sartopore® 2 is the industry standard of high-performance polyethersulfone (PES) liquid filters. A broad variety of different pore size combinations ensures highly economic and safe filtration performance. From single-layer high flow solutions to specific Mycoplasma retentive filters, Sartopore®2 perfectly adapts to your specific process needs.
Sartopore® Platinum is the high performance polyethersulfone (PES) filter platform from Sartorius Stedim Biotech. The innovative surface modification of the membrane leads to excellent wettability. Therefore, this filter family is perfectly suited for modern single-use applications, making processes highly economic, user friendly and safe. Using Sartopore® Platinum you will benefit from this cutting-edge membrane technology. For challenging processes, such as fill & finish, we offer a special filter type with an increased Bubble Point: Sartopore® Platinum HB.
Sartobran® P with its unique cellulose acetate (CA) membrane is mainly used for the sterile filtration of blood & plasma products as well as viral vaccines. The ultra-low binding feature of the membrane material leads to highest product yield. Especially large, shear-stress sensitive proteins do not lose their structure and function when filtered through this special membrane. This will improve your process output even further.
Sartolon filters are designed for broad chemical compatibility for specific applications in the pharmaceutical and chemical industry. The double-layer design leads to superior filtration performance compared to other nylon membrane filters and thereby allows more economical design of your filtration process. Sartolon filter elements are ideal for filtration of a broad range of solvents and solvent-containing liquids as well as oily formulations.