Virosart® HF Process Module 0.8 m², Gamma irradiated
- 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.
- 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
- 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
Risk Mitigation for Calcium Chloride Solution as an Additive to Cell Culture Media Using High Flux Virus Filters
Virus Filter Transfer Units (Gamma)
Virosart® — Highest virus safety for your patient — Next generation virus clearance concepts
Case Study: Robustness Study for Virus Filtration
Concept of a Fully Single-Use Virus Filtration
Virosart® HF 3VI--28-… Process Modules
Filter TypeVirus Filters
Capsule/Cartridge FormatFilter capsule
Filtration area0.8 m²
UsageDifficult to filter solutions
Connector Outlet¾" Tri-Clamp 25 mm
Connector Inlet1 ½" Tri-Clamp 50 mm
Primary Product TypeFilters
Delivery ConditionGamma irradiated
ApplicationmAB Production` Recombinant Protein Production
Sartocheck 4 cable to multiunit 0.5m
Order Number: 1ZE---0008
Sartocheck 4 cable to multiunit 2.0m
Order Number: 1ZE---0009
Sartocheck 4 cable to multiunit 5.0m
Order Number: 1ZE---0010
Sartocheck 4 network cable 2.0m
Order Number: 1ZE---0029
Sartocheck 4 network cable 5.0m
Order Number: 1ZE---0030
Sartocheck 4 network cable 10.0m
Order Number: 1ZE---0031
Sartocheck 4 network cable 20.0m
Order Number: 1ZE---0032