The Sartobran® P 0.1 µm disposable, sterile ready-to-use membrane filter capsules are designed for use in production of high value pharmaceutical and biotech products, due to the ultra low binding of their cellulose acetate membrane for proteins and preservatives. Applications: Typical applications include sterilizing grade filtration of any solution sensitive to adsorption like: – Therapeutics – Bioprocessed Pharmaceuticals – Serum – Injectables – Media – Buffers. Performance: The unique pleated filter construction and the "built-in-prefiltration" offers excellent flow rates and superior total throughput performance, especially in comparison to conventional stacked disc filter systems. High Product Yields: The highest product yields are realized by the combination of extremely low residual volume in the capsule housing and ultra low unspecific adsorption of the cellulose acetate membrane. Microbiological Retention: Sartobran® P 0.1 µm rated capsules are fully validated as sterilizing grade filter elements according to HIMA and ASTM F-838-05 guidelines. Quality Control: Each individual element is integrity tested by diffusion and bubble point test prior to release, assuring absolute reliability. Documentation: Sartobran® P 0.1 µm capsules are designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System. A Validation Guide and Extractables Guide are available for compliance with regulatory requirements.
All applications which require sterilizing grade filtration with retention finer than conventional 0.2 µm sterilizing grade filters for removal of unusually small microorganisms. This typically includes: - Bio-processed pharmaceuticals - Long term filling operations - Filtration in pharmaceutical water systems. Any other application requiring sub 0.2 µmfiltration for enhanced sterility assurance.
Easy to Use:
Sartobran P 0.45 μm Capsules are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated.
Higher flow rates than other 0.1 µm rated filters provide short filtration time and gentle product treatment, even if replacement of conventional 0.2 µm rated filters is necessary.
Highest Product Yield:
The ultra low adsorption characteristic of the Sartobran P’s cellulose acetate membrane provides the highest product yield – especially important for high value proteins.
Sartobran® P 0.1 µm filter elements are available with various filtration areas from 500 cm² to 1.8 m² for simple linear scale up and process flexibility.
Each individual element is integrity tested by diffusion and bubble point test prior to release, assuring absolute reliability.
Sartobran® P 0.1 μm Capsules are designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System. A Validation Guide and Extractables Guide are available for compliance with regulatory requirements.