Ultipor® VF Grade DV50 Virus Filter Cartridges - SBF Junior Style
Description
Ultipor VF Grade DV50 virus removal filters are a robust means to remove viruses from liquids by microfiltration, while permitting enhanced transmission of proteins. SBF Junior Style pleated membrane mini-cartridges are designed for small-scale qualification and validation studies and for small process batches up to 10 – 20 liters. Typical applications for these easy-to-use direct flow filters include purification of biopharmaceuticals, plasmaderivatives, protein or serum containing cell-culture media and diagnostic reagents.
Features and Benefits
- 6 log Titer Reduction (TR) for 50 nm viruses
- Robust size exclusion mechanism
- Narrow pore-size distribution
- Easy-to-validate direct flow use
- Linear scale-up to larger batches
- Low protein binding
- Low filter extractables
- 100% integrity-tested
- Pre-use testable with WFI
- Manufactured for use in conformance with cGMP
- ISO 9000 Certified Quality System
- Pharmaceutical P optimized
- Certificate of Test provided
- Validation Guide available
SBF style also available with 0.2 µm Ultipor® N66, Bio-Inert®, Posidyne®, Fluorodyne® II and Emflon® II media
Quality and Bio-Safety Biological Tests
- Integrity (100% Unit Release Test)
- Correlated to viral (phage) retention
Biological Tests
- Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests*
- Meets Cleanliness per USP Particulates in Injectables
- Non-Fiber-Releasing per 21 CFR
- Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
- Meets Total Organic Carbon and Water Conductivity per USP Purified Water; pH per Sterile Purified Water
Autoclave Resistance
Lot samples multi-cycle autoclave challenged
* Per lot samples soak or rinse-up flush aliquots
Specifications
Materials of Construction
| Membrane | Hydrophilic low protein binding polyvinylidenefluoride (PVDF) |
| Support and Drainage | Polyester |
| Core, Cage and End Caps | Polypropylene |
| O-ring | Silicone¹ |
¹ Other polymers available
Virus Removal Ratings²
| TR ≥ 106 for viruses ≥ 50 nm |
² Lot samples retain log 106 TR of 53 nm spherical non-enveloped bacteriophage PR772
Nominal Filter Area
| 0.074 m² (0.8 ft²) |
Nominal Dimensions
| Length | 62 mm (2.4 in.) |
| Diameter | 43 mm (1.7 in.) |
Configuration
| Single open-ended cartridge, sanitary style plug adapter, double 116 O-ring |
Autoclave and Steaming in situ³
| Autoclavable at 125 °C |
³ Contact Pall for recommended procedures
Operating Conditions
| Maximum Differential Pressure* | 3 bard (43.5 psid) |
| Recommended Operating Pressure | 1 - 2 bard (15 – 29 psid) |
| Maximum Differential Pressure for Integrity Test Performance (Short-term) | 6.0 bard (90 psid) |
* Viral TR pressure-independent
Aqueous Extractables (NVR)
| 1 mg per element in deionized water at 20 – 25 °C after autoclaving |
Type
Filter Cartridges
Use
Viral Safety
Related Documents
Regulatory/Quality Documentation
Ordering Information
| Part Number |
| SBF1DV50PH4* |
Note: For suggested qualification protocols, test and validation discs, sizing and sterilizing recommendations, SBF style cartridges with 0.2 µm or other grade, please contact Pall.
Product Summary
Ultipor VF Grade DV50 virus removal filters are a robust means to remove viruses from liquids by microfiltration, while permitting enhanced transmission of proteins. These SBF Junior Style pleated membrane mini-cartridges are designed for small-scale qualification and validation studies and for small process batches up to 10 – 20 liters
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