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Compact, Easily-scalable Filter Discs for Virus Removal and Small-scale Membrane Qualification Studies
Pegasus SV4 Virus Removal filters combine robust, high viral clearance of parvovirus and larger viruses with high throughput capacity and stable flowrates, in both dilute and complex concentrated biological fluids. Consistent flowrates and throughput performance provide superior control of process costs and maximizes virus filtration economy and efficiency.Pegasus SV4 Virus Removal Membrane Filter Discs are purpose-designed for small-scale membrane qualification studies such as bacteriophage or prion (TSE agent) clearance, as well as membrane flow rate, capacity and protein transmission studies. Filter discs are lot sample tested and manufactured under a Quality Management System certified to ISO 9001:2008 in order to assure consistently high quality.
Features | Benefits |
Pegasus SV4 virus removal filter membrane | Robust, high > 4 LRV parvovirus clearance |
Constant flow and high throughput performance | Maximize virus filter process economy and efficiency |
Identical membrane to larger production scale Pegasus SV4 virus filter cartridges | Offers reliable scalability |
Used in Pall FTK-200 disc holder | Easy handling |
Individual membrane box identified by lot number | Complete traceability of manufacturing history |
Manufacturing lot sample tested | Assurance of consistently high quality |
Membrane bacteriophage tested | Assurance of consistently high quality |
Pre- and post-use installation testable | Assurance of consistently high quality at point of use |
Low protein-binding | High protein recovery |
Robust membrane with high viral clearance and resistance to plugging | Flow decay minimized at high virus spike concentrations and with complex or concentrated feeds |
Materials
- Filter fluid path components have met the specifications under Section <88> Biological Reactivity Tests in vivo listed in the current revision of the United States Pharmacopeia (USP) for Class VI plastics at 121 °C.
Specifications
Technical Data
Materials of Construction
Item | Material |
Membrane | Hydrophilic modified polyvinylidene fluoride (PVDF) |
Support Disc | Polypropylene (Non-woven) |
O-ring (Disc Holder) | EPDM |
Disc Holder | Stainless steel |
Pore size
20 nm (nominal) |
Retention Ratings
Virus | |
Bacteriophage PP7 | > 4 log TR*† |
* Claims based on challenge with parvovirus model bacteriophage (bacterial virus) PP7
† > 4 LRV for PP7 bacteriophage per Parenteral Drug Association (PDA) TR 41 rating method for small virus-retentive filters > 4 LRV typically with mammalian parvoviruses
Effective Surface Area | |
11.1 cm2 (1.72 in.2) in FTK-200 Disc Holder | |
Operating Parameters** | |
Recommended Temperature | 4 - 45 °C |
Maximum Operating Pressure | 5 barg (73 psig) |
Maximum Differential Pressure | 4.5 bard (65 psid) |
Recommended Operating Differential Pressure | 2.1 – 3.1 bard (30 – 45 psid) |
** Maximum air/gas pressure for installation test is 6.2 barg (90 psig)
Type
Disc Filters
Use
Viral Safety
Related Documents
Regulatory/Quality Documentation
Ordering Information
Part Number | Description |
FTKSV404705 | Filter Discs1 |
FTKSV4047025 | Filter Discs2 |
1 Five discs per box, 2 Twenty-five discs per box
|Part Number | Holder |
FTK-200 Disc Holder | FTK-200 |
Further Equipment Recommended for Laboratory Testing
Part Number | Pressure Vessels (Stainless steel) |
ZLK702G23LHKH4 | Sealkleen™ vessel |
Part Number | Accessories (Sealkleen Vessel) |
GFX0290 | Adapter 1 in. TC/Male Stäubli connector plug (3 mm) R 1⁄4 in. |
GFX0390 | Adapter 1 in. TC connector plug R 1⁄4 in. NPT (FTK-200 inlet fitting) |
GFX0235 | Male Stäubli connector plug (3 mm) R 1⁄4 in. |
Part Number | Pressure Vessels (Disposable) |
C3EP1 | Novasip™ vessel |
Part Number | Accessories (Novasip Vessel) |
GFX0290 | Adapter 1 in. TC/Male Stäubli connector plug (3 mm) R 1⁄4 in. |
SLK1TC23H4 | TC clamp + gasket silicone |
Product Summary
Compact, easily-scalable filter discs for virus removal and small-scale membrane qualification studies
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