Virosart® Media Process Module 1.0 m² - Non-sterile Delivery

Application:

• Target molecule: The main application for Virosart® Media is virus retentive filtration of chemically defined cell culture media.
• Virus clearance: Virosart® Media targets the removal of small non-enveloped adventitious viruses (20 nm) e.g. MVM or vesivirus from chemically defined cell culture media.
• Positioning: Virosart® Media is used after the media preparation step itself before transferring the media into the bioreactor. This can be operated either as in-line filtration (e.g. perfusion) or batch filtration. Performance of the Virosart® Media is independent of the use of powder or liquid media but could be strongly impacted by the media itself. Virosart® Media is optimized for chemically defined media. Protein transmission for mAbs and recombinant proteins is not given for this filter.

Product benefits:

• Robust virus clearance: Virosart® Media provides high virus safety to the bioreactor as it is qualified for ≥ 4 LRV (Log10 reduction value) of small non-enveloped viruses (e.g. MVM) and ≥ 6 LRV for large enveloped viruses.
• Short processing times: Based on the optimized Polyethersulfone membrane, Virosart® Media provides highest flow rates and excellent capacity for cell culture media (e.g. ≥ 1000 L/m2 in 4 h).
• Smart process transfer: The hollow fiber format supplies highest consistency and scalability from lab to process scale.
• Cost efficiency: The high packing density of the elements combines extremely low hold up with low footprint requirements.
• Ready to use: The sterile delivery secures ease of use as well as fast installation of the filter elements.
• Ease of use: Virosart® Media 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 module is tested for integrity and for water flow rate during manufacturing
• 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