Virosart® HF Process Module 0.8 m² - Sterile Delivery

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Virosart® HF Process Module 0.8 m² - Sterile Delivery Virosart® HF Process Module 0.8 m² - Sterile Delivery Virosart® HF Process Module 0.8 m² - Sterile Delivery Virosart® HF Process Module 0.8 m² - Sterile Delivery Virosart® HF Process Module 0.8 m² - Sterile Delivery
 

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.

Filtration Area
Delivery Condition
Item No.: 
3VI--28-HCGSF
Availability: 

*Custom/bulk order quotes are provided within 72 hours of request.

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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
  • USP Plastic Class Test VI

Applications

  • Application
    • mAB Production
    • Recombinant Protein Production

Connections (Physical)

  • Connector Inlet
    1.5" Tri-clamp 50 mm
  • Connector Outlet
    3/4" Tri-clamp 25 mm

Dimensions

  • Filtration Area
    0.8 m² | 8.6 ft²

Features

  • Integrity Tested
    Yes

General Specifications

  • Capsule/Cartridge Format
    Filter capsule
  • Filter Format
    Filter Capsules

Materials of Construction

  • Filter Material
    Polyethersulfone (PES)

Physicochemical Information

  • Pore Size
    20 nm (nominal)

Product Information

  • Brand
    Virosart® HF
  • Pack Size
    1

Sterility/Purity

  • Delivery Condition
    Sterile - Gamma irradiated
  • Sartocheck® 5 Plus Filter Tester
    Sartocheck® 5 Plus Filter Tester
    Item no.
    26787---FT---P

    The Sartocheck® 5 Plus Filter Tester is an automatic filter integrity tester with automated Quality Risk Management (QRM) designed to cover the complete range of integrity testing from small syringe filters up to large multi-round housings and tangential flow cassettes.

  • IT Wetting Kit - Virosart® HF 0.8 m²
    IT Wetting Kit - Virosart® HF 0.8 m²
    Item no.
    FFU5002AS

    IT Wetting Kit for Virosart® HF 0.8 m² for the easy wetting of the Virosart® HF filter element before a pre-use integrity test.

  • Virosart® Max 10" T-Style Maxicaps®
    Virosart® Max 10" T-Style Maxicaps®
    Item no.
    54A8358N1--SS

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