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Virosart® HF Mid-Scale Module 200 cm², Non-Sterile

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.

Item no.:  3VI--28-DC-FO

   

Application:

  • Virus clearance: Virosart® HF targets the removal of both small non-enveloped viruses (20 nm) e.g. PPV, MVM and larger enveloped viruses (> 50 nm) e.g. MuLV from biopharmaceutical feed streams.
  • Target molecule: The main application for Virosart® HF filters is the virus filtration of monoclonal antibodies (mAbs), antibody fragments (Fab) or small recombinant proteins (< 150 kD).
  • Positioning: Virosart® HF 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® HF 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.
  • Short processing times: Based on a unique modified PES membrane, Virosart® HF provides highest flow rates and excellent capacity.
  • 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 and flushing volumes 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® HF 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 and for water flux 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

Application Note

Application Guide - Virosart® HF: High Speed Virus Filtration for mAbs and Recombinant Proteins
en 1.8 MB

Poster

Case Study: Robustness Study for Virus Filtration
en 194.2 kB
Case Study: Increasing Virus Filter Throughput by Process Optimization Studies
en 301.3 kB
Poster_Case-Study_Virus-Filter_Throughput_BK_A2-e.pdf
en 263.7 kB

Applications

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

Connections (Physical)

  • Connector Inlet
    ¾" Tri-Clamp 25 mm
  • Connector Outlet
    Hose barb

Dimensions

  • Filtration Area
    200 cm²
  • Height
    187 mm

Features

  • Integrity Tested
    Yes

Product Information

  • Filter Type
    Virus Filters
  • Primary Product Type
    Filters

Specifications

  • Capsule/Cartridge Format
    Filter capsule

Sterility

  • Delivery Condition
    Non - Gamma irradiated
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Virosart® CPV Capsule height 4
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Virosart® Max Capsule height 4
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