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Virosart® HF Mid-Scale Module 0.2 m², Gamma irradiated

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-FCGFO

   

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

Risk Mitigation for Calcium Chloride Solution as an Additive to Cell Culture Media Using High Flux Virus Filters
en 1.5 MB
Impact of Pressure Release and Multiple Pressure Fluctuations on Virus Retention Performance of Virosart® HF Virus Retentive Filters
en 1.1 MB
Application Guide - Virosart® HF: High Speed Virus Filtration for mAbs and Recombinant Proteins
en 1.8 MB

Datasheet

Datasheet Virosart HF
en 1.4 MB
Virus Filter Transfer Units (Gamma)
en 548.5 kB

Flyer

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

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
Concept of a Fully Single-Use Virus Filtration
en 844.5 kB

User Manual

Manual Virosart® HF Mid-Scale Modules
en 207.7 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
    0.2 m²
  • Height
    327 mm

Features

  • Integrity Tested
    Yes

Product Information

  • Filter Type
    Virus Filters
  • Primary Product Type
    Filters
  • Sterilization Method
    Gamma irradiation

Specifications

  • Capsule/Cartridge Format
    Filter capsule
Midisart® 2000
Midisart® 2000
Item no.: 17805--------TCN

Midisart® filters are available with PTFE (autoclavable) or PES (gamma-irradiatable | autoclavable) membrane. Ready-to-use, 100 % integrity tested and fully validated.

Virosart® HC MidiCap® height 9
Virosart® HC MidiCap® height 9
Item no.: 5395328V9--FF--V

The high capacity virus filter for robust and efficient removal of small non-enveloped and large enveloped viruses in blood & plasma applications.

Virosart® CPV MidiCap height 9
Virosart® CPV MidiCap height 9
Item no.: 5455328V9--FF--V

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.

Virosart® Max MidiCap® height 9
Virosart® Max MidiCap® height 9
Item no.: 54A5358N9--FF--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.

MidiCaps® Holder
MidiCaps® Holder
Item no.: 5ZGLG-0007

The Sartorius Stedim Biotech MidiCaps® holder has been specially designed to integrate MidiCaps® into biopharmaceutical processes.

MaxiCaps® Filter Holders

The Sartorius Stedim Biotech MaxiCaps® holder has been specially designed to integrate MaxiCaps® into biopharmaceutical processes.

Midisart®

Midisart® filters are available with PTFE (autoclavable) or PES (gamma-irradiatable | autoclavable) membrane. Ready-to-use, 100 % integrity tested and fully validated.