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
优势
- 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 Test
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.- 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
材料成分
| 项目 | Material |
| 膜 | Hydrophilic modified polyvinylidene fluoride (PVDF) |
| Support Disc | Polypropylene (Non-woven) |
| O-ring | EPDM |
| Capsule Inlet and Outlet | 聚碳酸酯 |
Removal Rating
| 项目 | 过滤 |
| 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 |
| 最大操作压力 | 3.1 barg (45 psig) |
| Maximum Differential Pressure | 3.1 barg (45 psig) |
Typical Flow vs.Differential Pressure
Typical Clean Water Flow at Ambient Conditions
使用说明：Minidisc Virus Removal Filter Capsules (PDF, 500 kb)
| 描述 | 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 |
