Virosart® Max Capsule Size 4

Application:

• Positioning: The main application for Virosart^® Max* is the protection of the final virus retentive membrane. For that purpose this filter is used at the end of the purification process in-line with the final virus filtration step of the biopharmaceutical product. The optimized pre-filter – final-filter ratio should be determined during development of the virus filtration step.
• Working principle: Virosart^® Max* combines size exclusion mechanism with efficient adsorptive capacities to increase the robustness of the following virus filtration step. The most challenging molecules for the final virus retentive membrane are aggregates and | or small hydrophobic molecules. Virosart^® Max binds aggregates very efficiently through hydrophobic interactions, independently of process conditions such as conductivity.

Product Benefits:

• Cost efficiency: The combination of size exclusion mechanism with efficient adsorptive capacities, will downsize your process and reduce your total virus filtration costs.
• Fast installation: With the T-Style design the Virosart^® Max MaxiCap^® is ideal for easy installation of multiple filters in series or parallel.
• Smart process transfer: The clean triple layer membrane material provides highest adsorptive capacities optimized for this process step and scalability from lab to process scale.
• Ready to use: The sterile delivery secures ease of use as well as fast installation of the filter elements.
• Ease of use: Virosart^® Max 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
• 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

* The patented technology (DE 10 2011 105 525 B4) binds aggregates efficiently through hydrophobic interactions with polyamide, independently of process conditions such as conductivity from biological feed streams (mAbs, plasma derivates or recombinant proteins).