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Virosart® CPV Minisart IT tested

The PES based virus filter for robust and efficient removal of small non-enveloped and large enveloped viruses in biopharmaceutical applications. Virosart® CPV is the optimal virus filter for monoclonal antibodies or small recombinant proteins.

Item no.:  545VM--------ITB

Virus filtration with Virosart® is an integral part of the orthogonal virus clearance technology platform of Sartorius Stedim Biotech. This orthogonal technology platform features virus filtration, virus inactivation and virus adsorption. The Virosart® product range includes three different virus retentive membranes, in order to provide the best solution for every application.

Virosart® CPV is the optimal virus filter for monoclonal antibodies (Mab), antibody fragments (Fab) or small recombinant proteins (>150kDa). Virosart® CPV is used at the end of the purification process for virus retentive filtration of the biopharmaceutical product. At this stage the purity of the biopharmaceutical product is the highest and virus filter blockage due to contaminants (DNA, CHOP, aggregates & lipoproteins) is the lowest.

Virosart® CPV provides highest virus safety of the biopharmaceutical product. The filter retains more than 4 log10 of small non-enveloped viruses (e.g. PPV, MVM) and more than 6 log10 of large enveloped viruses (e.g. MuLV). Based on the unique double layer 20nm PES membrane, Virosart® CPV provides excellent flow rates and superior capacity. This filter offers highest virus safety over the entire flow decay profile. The performance of the final virus filter mainly depends on the feed stream properties. Therefore, appropriate feed stream conditioning i.e. through efficient pre-filtration is a major aspect with the development of a virus filtration step.

Scale down work is realized using the Virosart® CPV Minisart (5 cm2 capsule) to enable filtration work for flow and capacity studies as well as for GLP virus spiking studies. Scale up studies are performed using Virosart® CPV capsule and|or MidiCaps® (180 cm2 | 2.000 cm2) to reliably scale up into larger scale manufacturing. Large scale manufacturing is operated with Virosart® CPV MaxiCaps® or cartridges.

Virosart® CPV filters are tested for integrity using a water based integrity test with the Sartocheck® technology of Sartorius Stedim Biotech. Virosart® CPV filters have been validated for 4 log10 removal of small non-enveloped viruses using bacteriophage PP7 as the model virus. Validation data is shown in the validation guide of Virosart® CPV. Each individual Virosart® CPV filter is autoclaved and integrity tested during manufacture assuring highest product reliability. Virosart® CPV filters are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements.

Flyer

Virosart® — Highest virus safety for your patient — Next generation virus clearance concepts
en 886.6 kB

User Manual

Virosart® CPV Minisart®
en 189.1 kB

Applications

  • Application
    • mAB Production
    • Recombinant Protein Production
  • Industry
    Pharma/Biotech
  • Usage
    Easy to filter solutions

Connections (Physical)

  • Connector Inlet
    Luer Lock
  • Connector Outlet
    Luer Lock

Dimensions

  • Filtration Area
    5 cm²
  • Height
    27 mm

Features

  • Integrity Tested
    Yes

Product Information

  • Filter Type
    Virus Filters
  • Primary Product Type
    Filters

Specifications

  • Filter Format
    Capsules
Virosart® HF Lab Module 5.0 cm², Integrity Tested

New high speed virus filtration.

The high flux PES based virus filter for robust and efficient removal of small non-enveloped and large enveloped viruses in biopharmaceutical applications.

Virosart® Max Minisart
Virosart® Max Minisart
Item no.:   54AMI----------B

Maximize your virus filter performance with adsorptive pre-filtration. Virosart® Max is a specifically optimized virus pre-filter significantly increasing downstream virus filter performance.

Virosart® Max Sartolab
Virosart® Max Sartolab
Item no.:   54ASA----------V

Maximize your virus filter performance with adsorptive pre-filtration. Virosart® Max is a specifically optimized virus pre-filter significantly increasing downstream virus filter performance.