Integrated Membrane for Single-Use Filtration Assemblies Saves Set-Up and Validation Time

Sartorius Stedim Biotech’s (SSB) polyethersulfone membrane (PESU) is now integrated into two new, sterile Sartocon benchtop and production-scale filtration assemblies. Using these assemblies guarantees rapid and safe ultrafiltration of biologics and vaccines. Due to the fully enclosed design, the Sartocon assemblies are ideal for safely purifying vaccines and recombinant proteins, as well as monoclonal antibody manufacturing, and are suitable for use in cGMP environments for process development, clinical trials, and small-scale production batches.

The new, single-use Sartocon Self-contained Filter Loop Assembly has been developed for use with SSB’s unique control unit, the FlexAct UD, and the Sartocon Slice Self-contained Bag Loop Assembly has been designed for SSB’s benchtop crossflow system SARTOFLOW Alpha plus SU. Both assemblies are supplied gamma sterilized and ready to use. The integrated PESU membrane is pre-wetted and flushed, which saves set-up and validation time, as well as eliminates the costs of using buffers and purified water to prepare the membrane.

Because the Sartocon assemblies are designed with the same hydrodynamic flow path as SSB’s larger production-scale filter devices, and all device materials and accessories are manufactured to the same industrial quality-assured specifications, linear scale-up and process transfer is a simple process. The PESU membrane inside the Sartocon assemblies is available in several sizes and 10-300 KDa molecular weight cut-offs and is robust enough for use in broad pH and temperature ranges. These features combined with the Sartocon assemblies’ single-use design, which prevents product cross-contamination, means they are perfect for use in R&D applications, at contract manufacturing organizations, and at multi-product facilities. In addition to the PESU membrane, SSB’s Hydrosart membrane is another option, available since 2015, for single-use Sartocon filter loop assemblies.

Source: SSB