Virosart® HC Minisart® - Integrity Tested

Application:

• 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 main applications for Virosart^® HC for virus filtration are hydrophobic feed streams such as IVIG or any other plasma derivates as well as hydrophobic antibodies & recombinant proteins (< 150 kD).
• Positioning: Virosart^® HC is used towards the end of the purification process of biopharmaceutical products for the virus filtration. At this stage, the purity of the biopharmaceutical product is at its highest and so fouling of the filter by contaminants (DNA, CHOP, aggregates & 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 offers highest virus safety over the entire flow decay profile independently of operating pressure.
• Smart process transfer: Flexibility is give by using either cartridges in existing stainless steel housings or disposable capsules.
• Ease of use: Virosart^® HC are tested for integrity using a water-based diffusion test, e.g. based on the Sartocheck^® technology of Sartorius Stedim Biotech

Regulatory Compliance:

• Each individual filter is tested for integrity
• Validated for ≥ 4 LRV removal 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 requirements for WFI quality standards set by the current USP
• Non pyrogenic according to USP Bacterial Endotoxins
• USP Plastic Class Test VI