
Ultipor® VF Grade DV20 Virus Removal Filter Membrane in Minidisc Capsules
Description
Minidisc filter capsules incorporate Ultipor® VF Grade DV20 membrane and are validated for virus removal.
They are also suitable 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. Every filter is identified by a lot number and a unique serial number for complete traceability of manufacturing history and for user’s traceability system and manufactured under a Quality Management System certified to ISO 9001:2008.
They are also suitable 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. Every filter is identified by a lot number and a unique serial number for complete traceability of manufacturing history and for user’s traceability system and manufactured under a Quality Management System certified to ISO 9001:2008.
Key Features
- Incorporates Ultipor VF Grade DV20 virus removal filter membrane
- Identical membrane to larger virus cartridges
- Fully disposable capsule with Luer-Lok* connections
- Individual capsules identified by lot and serial number
- 100% manufacturing assembly tested
- Membrane bacteriophage tested
- Pre- and post-installation tested
- Low protein-binding
- Robust membrane with high viral clearance and resistance to plugging
Benefits
- Robust, high viral clearance
- Reliable scalability
- Easy handling, ready to use
- Easy identification of individual capsules with complete traceability of manufacturing history
- Assurance of consistently high quality at point of use
- Flow decay minimized at high virus spike concentrations and with more complex or concentrated feeds
High Quality Standards
Meets the current USP requirements under Section <85> Bacterial Endotoxins TestMaterials
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
Materials of Construction
Item | Material |
Membrane | Hydrophilic modified polyvinylidene fluoride (PVDF) |
Support Disc | Polypropylene (Non-woven) |
O-ring | EPDM |
Capsule Inlet and Outlet | Polycarbonate |
Removal Rating
Item | Removal |
Small viruses | > 3 log TR*† |
Large viruses | > 6 log TR ** |
** Claims based on challenge with parovirus model bacteriophage (bacterial virus) PR772
† > 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
9.6 cm² (1.49 in²) |
Operating Parameters²
Maximum Temperature | 25 °C |
Maximum Operating Pressure | 3.1 barg (45 psig) |
Maximum Differential Pressure | 3.1 barg (45 psig) |
Applications
- Virus removal and small-scale membrane qualification studies such as bacteriophage or prion (TSE agent) clearance
- Membrane flow rate studies
- Capacity studies
- Protein transmission studies
Performance
Typical Flow vs. Differential Pressure
Typical Clean Water Flow at Ambient Conditions
Type
Filter Capsules
Use
Viral Safety
Related Documents
Instructions For Use - Minidisc Filter Capsules with Ultipor® DV20 Virus Removal Filter Membrane
Regulatory/Quality Documentation
Ordering Information
Description | Part Number* |
Minidisc Capsules with Ultipor® VF Grade DV20 Membrane | 10MCFDV20 |
Equipment Required for Laboratory Testing
Pressure Vessels | Part Number |
Junior-style vessel | BLS7001G23J |
Sealkleen vessel | ZLK702G23LHKH4 |
Novasip™ vessel | C3EP1 |
Accessories (Novasip Vessel) | Part Number |
Adapter 1 in. TC/Male Stäubli connector plug (3 mm) R ¼ in. | GFX0290 |
TC clamp + silicone gasket | SLK1TC23H4 |
Accessories (Junior, Sealkleen Vessels) | Part Number |
Adapter 1 in. TC/Male Stäubli connector plug (3 mm) R ¼ in. | GFX0290 |
Male Stäubli connector plug (3 mm) R ¼ in. | GFX0235 |
Product Summary
Minidisc filter capsules incorporate Ultipor® VF Grade DV20 membrane and are validated for virus removal. Also suitable 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