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Ultipor® VF Grade UDV20 Virus Removal Filter Cartridges
Robust, Small-Virus Removal Filter with consistent, High Flow Performance
The risk of virus contamination is ever-present in biologic products. Potential sources of virus contamination of biotechnology products include viruses associated with the cell lines (endogenous viruses), or viruses introduced into the cell line or product during from culture medium or during the production process (adventitious viruses). Viruses could potentially be present in donations for plasma derivatives. Ultipor® VF UDV20 Virus Removal Filter Cartridges are direct flow filters that provide an efficient and economical method for removing even the smallest viruses from biological solutions and meet the acceptance criteria of the Parenteral Drug Association’s virus filter task force for small pore size virus-retentive filters.Features
- Incorporates Ultipor VF DV20 virus filter membrane
- Proven, reliable virus safety technology
- High filtration area per filter cartridge
- Robust, stable flowrate
- Resistant to plugging
- Rigorous quality testing
- Autoclavable and Steamable In Place (SIP)
- Automatic in-line integrity test
- Fully automated systems available
Benefits
- Robust, high viral clearance for small viruses
- Approved for use in licensed processes
- Maximizes process productivity, reduces Cost of Goods
- Stable flux rates achievable in a wide range of process conditions. Consistent performance (suitable for platform technology)
- Minimized flux decay
- Provides assurance of consistent performance per specification
- Enables a sterile process where required
- Reduces labor costs, minimizes risk of handling errors
- Enables the highest level of process control and safety
Robustness and Resistance To Plugging
Ultipor VF UDV20 filter cartridges are characterized by robust and stable high performance, over a wide range of process conditions. The innovative hydrophilic PVDF membrane provides stable pressure/flux capabilities also in more complex or concentrated feeds. The unique, patented laid-over pleating technology provides 2x increased effective filtration area. This allows economical virus filtration of high concentrated protein solutions, without product dilution. Flow decay due to membrane plugging and gel polarization is minimized for a wide range of different process conditions and over long process times, which qualifies Ultipor VF UDV20 filters as platform technology.
High Area-Per-Filter-Cartridge
The Ultipor VF UDV20 filter is an extension to the Ultipor VF Grade DV20 virus filter line. The high-filter-area-per-filter cartridge (due to its unique, patented laid-over pleating construction and narrow core) maximizes process productivity, reduces process costs and reduces the required amount of filter elements per installation, which minimizes the hold up volume of the virus filter system.
Automated Systems
Pall offers fully-automated virus filtration systems that enable precise and consistent operation, together with improved process efficiency. The systems can be designed with steam sterilization (SIP), automated cleaning (CIP) and integrity test in place (ITIP). The Cluster-Filtration Technology assures maximum filter integrity sensitivity. Pall's fully automated virus filtration systems ensures the highest level of manufacturing safety and process performance.
Rigorous Quality Testing
- 100% Integrity tested – correlated to PP7 bacteriophage removal
- PP7 bacteriophage lot release test
- 100% water flow test
- Protein transmission test
- Visual inspection control
- Quality Control at Multiple Production Stages
- Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
- Meets Cleanliness per USP Particulates in Injectables
- Non-Fiber-Releasing
- Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
- Meets Total Organic Carbon and Conductivity per USP Purified Water; pH per Sterile Purified Water
Published Articles
Poster: Scalability of Ultipor® VF DV20 and UDV20 Virus Removal Cartridges (PDF, 100 kb)
Specifications
Operating Conditions
¹ Contact Pall for recommended procedures to qualify filters under actual conditions of use
² Claims based on challenge with parovirus model bacteriophage (bacterial virus) PP7
³ > 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.
4 Claim based on challenge on retrovirus model bacteriophage PR772 – ≥ 6 LRV typically also with mammalian retroviruses
5 Correlated to > 3 log TR for 25 nm PP7 phage and > 6 log TR for 53 nm PR772 phage
Materials Of Construction
| Membrane | Hydrophilic modified polyvinylidene fluoride (PVDF) |
| Support and Drainage Layers | Polyester |
| Core, Cage and Endcaps | Polypropylene |
| Code 7 adapter | Polypropylene with encapsulated stainless steel reinforcing ring |
| O-rings | Silicone |
Operating Conditions
| Recommended Operating Delta P | 1 to 3.1 bard (14.5 to 45 psid) |
| Maximum Differential Pressure | 3.1 bar (45 psi) for continuous service 0.3 bar (5 psi) during steam sterilization 6.2 bar (90 psi) during integrity testing |
Autoclave/Steaming ¹
| Autoclavable or steamable in-situ | Up to 3 cycles |
| Maximum Temperature | 125 °C |
Removal Rating
| Small viruses ² | ≥ 3 Log TR³ |
| Large viruses | ≥ 6 Log TR4 |
³ > 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.
4 Claim based on challenge on retrovirus model bacteriophage PR772 – ≥ 6 LRV typically also with mammalian retroviruses
Typical Aqueous Extractables (NVR)
| < 15 mg per 254 mm (10 in) element, process-ready (after integrity testing, water flush and autoclaving) |
Filter Area (nominal)
| 2 m² (22 ft²) per 254 mm (10 in.) element |
Forward Flow Integrity Test 5
| Diffusional flow integrity test, carried out by standard upstream or downstream methods |
Performance
PPV = Porcine parvovirus
MMV = Mouse Minute virus
B19 = Human parvovirus
X-MuLV = Xenotropic Murine Leukemia virus
A-MuLV = Amphotropic Murine Leukaemia virus
HIV = Human immunodeficiency virus
BVDV = Bovine Viral Diarrhea virus
Typical Parvovirus Reduction by Ultipor VF UDV20 Virus Removal Filter Cartridges
| Product Type | Log Reduction Value: | Log Reduction Value: | Log Reduction Value: |
| mAb 1 | 6.3 | - | - |
| mAb 2 | - | 6.2 | - |
| mAb 3 | - | > 5.8 | - |
| mAb 4 | - | 5.1 | - |
| mAb 5 | > 5.8 | - | - |
| mAb 6 | > 5.0 | - | - |
| mAb 7 | 4.2 | - | - |
| hIgG 1 | > 4.8 | - | - |
| hIgG 2 | - | - | > 5.0 |
| hIgG 3 | > 6.6 | - | - |
MMV = Mouse Minute virus
B19 = Human parvovirus
Effective Reduction of Large Viruses by Ultipor VF UDV20 Virus Removal Filter Cartridges
| Product Type | Log Reduction Value: | Log Reduction Value: | Log Reduction Value: | Log Reduction Value: |
| mAb 1 |
|
| > 5.6 | - |
| mAb 2 |
|
| > 5.3 | - |
| mAb 3 |
|
| > 5.1 | - |
| mAb 4 |
|
| > 5.7 | - |
| mAb 5 |
|
| - | > 6.0 |
| mAb 6 |
|
| > 5.4 | - |
| mAb 7 |
|
| > 4.9 | - |
| mAb 8 |
|
| - | > 5.7 |
| mAb 9 |
|
| > 5.4 | - |
| mAb 10 |
|
| > 4.6 | - |
| hIgG 1 | > 5 | > 5 |
|
|
| hIgG 2 | > 6.2 | > 5.4 |
|
|
| hIgG 3 | > 5 | > 4.6 |
|
|
| hIgG 4 | > 4.6 | > 6.1 | ||
A-MuLV = Amphotropic Murine Leukaemia virus
HIV = Human immunodeficiency virus
BVDV = Bovine Viral Diarrhea virus
Additional Information
See also Pall publication USTR 2612: ‘Scalability of Ultipor® VF Grade DV20 and UDV20 Virus Removal Filter Cartridges’
Process Scale-up with Ultipor VF Grade DV20 Virus Filters
| Filter Format | Part Number | Nominal Filtration Area |
| Minidisc Capsule | 10MCFDV20 | 0.00096 m² |
| 47mm Disc in FTK200 Holder | FTKDV20047 | 0.0011 m² |
| Novasip™ Capsule | CLM05DV20P1G | 0.07 m² |
| 10 in. Fanpleat | AB1DV207PH4 | 1 m² |
| 10 in. Laid-over Pleat | AB1UDV207PH4 | 2 m² |
Ordering Information
| Description | Part Number |
| 254 mm (10 in.) cartridge, double 226 O-ring adapter with bayonet lock and finned end, seal material silicone elastomer | AB1UDV207PH4 |
| 508 mm (20 in.) cartridge, double 226 O-ring adapter with bayonet lock and finned end, seal material silicone elastomer | AB2UDV207PH4 |
| 762 mm (30 in.) cartridge, double 226 O-ring adapter with bayonet lock and finned end, seal material silicone elastomer | AB3UDV207PH4 |
Application
Filters - Specialist
Segment
Viral Clearance
فروشنده: واردکننده
گارانتی اصالت و سلامت کالا
پشتیبانی ۷ روز هفته ۲۴ ساعته
۰ تومان
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