Virosart HC
High-capacity virus filter for robust and efficient removal of small non-enveloped and large enveloped viruses in blood and plasma applications.
Applications
Virus clearance: Virosart® HC retains ≥ 4 LRV of small non-enveloped viruses (e.g. PPV, MVM) and ≥ 6 LRV of large enveloped viruses (e.g. MuLV).
Target molecule: The primary applications of Virosart® HC for virus filtration are hydrophobic feed streams such as IVIG or other plasma derivatives, as well as hydrophobic antibodies and recombinant proteins (< 150 kD).
Positioning: Virosart® HC is used toward the end of the purification process of biopharmaceutical products for virus filtration. At this stage, the purity of the biopharmaceutical product is at its highest level, and therefore fouling of the filter by contaminants (DNA, CHOP, aggregates, and lipoproteins) will be low.
Product Benefits
Robust virus clearance: Virosart® HC retains ≥ 4 LRV of small non-enveloped viruses (e.g. PPV, MVM) and ≥ 6 LRV of large enveloped viruses (e.g. MuLV). This filter provides the highest virus safety across the entire flow decay profile regardless of operating pressure.
Smart process transfer: Flexibility is achieved using cartridges in existing stainless steel housings or single-use capsules.
Ease of use: Virosart® HC is integrity-tested using a water-based diffusion test, e.g. based on Sartorius Stedim Biotech's Sartocheck® technology.
Regulatory Compliance
- Each filter is integrity tested
- Validated for removal of ≥ 4 LRV of small non-enveloped viruses using bacteriophage PP7
- Designed, developed, and manufactured in accordance with an ISO 9001 certified Quality Management System
- Meet or exceed the WFI quality standard requirements specified by the current USP
- Non-pyrogenic according to USP Bacterial Endotoxins
- USP Plastic Class Test VI
