25-58234 - Automatic Filter Integrity Testing System

The National Research Council (NRC) Human Health Therapeutics (HHT) Research Center has a requirement for an automatic filter integrity testing system to support purification process development for recombinant proteins, viruses, and virus-like particles. The equipment will be used to verify the integrity of filtration devices across a range of scales, from small-scale syringe filters to large-scale production filters and Tangential Flow Filtration (TFF) cassettes.
The system must operate safely within Biosafety Level 2 (BSL-2) environments, enabling integrity testing to be performed directly under a Biosafety Cabinet (BSC) or equivalent containment without prior decontamination. This capability is essential for protecting personnel from aerosol exposure and ensuring accurate, contamination-free results during biotherapeutic purification and validation activities. The system must also provide robust protection of internal pneumatic components, ensuring reliable operation and minimizing maintenance requirements.
Following a review of available technologies, Sartorius Stedim North America has been identified as the supplier currently capable of providing a system that meets all of NRC’s functional and safety requirements for automated filter integrity testing.