Skip to content Skip to navigation menu

Virosart® HF Process Module 0.8 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-HCGSF

Availability (ex works):  On Request

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
Appl_Virosart_HF_SPK4112-e.pdf
en 1.1 MB
Appl-Guide_Virus-Filtration-Virosart-HF-e.pdf
en 1.8 MB

Datasheet

Data_Virosart_HF_Capsule_Family_SPK2180-e.pdf
en 1.3 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
Poster_Case-Study_Virus-Filter_Optimization_A2-e.pdf
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

Virosart® HF 3VI--28-… Process Modules
en 171.4 kB

Applications

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

Connections (Physical)

  • Connector Inlet
    1½" Tri-Clamp 50 mm
  • Connector Outlet
    ¾" Tri-Clamp 25 mm

Dimensions

  • Filtration Area
    0.8 m²
  • Height
    330 mm

Features

  • Integrity Tested
    Yes

Product Information

  • Filter Type
    Virus Filters
  • Primary Product Type
    Filters

Specifications

  • Capsule/Cartridge Format
    Filter capsule

Usage Protocols

  • Sterilization Method
    Gamma irradiation
MaxiCaps® T-Style Holder
MaxiCaps® T-Style Holder

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

Item no.:   5ZGI--0008
MaxiCaps® Holder single round
MaxiCaps® Holder single round

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

Item no.:   5ZGI--0010
MaxiCaps® Holder 3-round
MaxiCaps® Holder 3-round

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

Item no.:   5ZGI--0011
MaxiCaps® Filter Holders
MaxiCaps® Filter Holders

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

Item no.:  
Virosart® HC 10" T-StyleMaxiCap®
Virosart® HC 10" T-StyleMaxiCap®

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

Item no.:   5398328V1--SS
Virosart® CPV 20" MaxiCaps® - New Design
Virosart® CPV 20" MaxiCaps® - New Design

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.:   5457328V1--SS
Sartocheck® 4 Plus Filter Tester v 3.2
Sartocheck® 4 Plus Filter Tester v 3.2

Fully automatic filter integrity testing device. In full compliance with 21 CFR Part 11 and GAMP5. A large accessory package makes Sartocheck 4 plus flexible, powerful and creates safe solutions for almost all customer needs.

Item no.:   26288---FT
Virosart® Max 10" T-Style MaxiCap®
Virosart® Max 10" T-Style MaxiCap®

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

Item no.:   54A8358N1--SS
Sartocheck 4 plus Bag Tester
Sartocheck 4 plus Bag Tester

The Sartocheck® 4 plus Bag tester is the result of a clear market request for testing single use bags and bioreactors, pre-use and post-use. It is based on the same market leading software and hardware platform as the Sartocheck® 4 plus Filter tester and assures full communication compatibility between the both.

Item no.:   26288---BT
Sartocheck 4 plus Bag Tester MultiUnit
Sartocheck 4 plus Bag Tester MultiUnit

The Sartocheck® 4 plus Bag tester MultiUnit is a perfect copy of the Sartocheck 4 plus Bag tester but without the user interface. Up to four MultiUnits may be connected to one Sartocheck 4 plus Bag tester or to a Sartocheck 4 plus Filter tester thus allowing up to five tests in parallel.

Item no.:   26288---BM
Sartocheck® 4 Plus Filter Tester MultiUnit
Sartocheck® 4 Plus Filter Tester MultiUnit

Fully automatic filter integrity testing device without user interface. Up to 4 units may be connected to one main unit for 5 tests in parallel. 21 CFR p 11 and GAMP5 compliant. A large accessory package gives solutions for almost all customer needs.

Item no.:   26288---FM