Description
Integrity testable, direct flow filters for size exclusion removal of viruses
Ultipor® VF Grade DV20 Virus Removal Filter cartridges are suitable for size exclusion removal of viruses as small as 20 nm from biological solutions. The innovative, DV20 hydrophilic PVDF microporous membrane also enables > 95% transmission of proteins up to 160 kiloDaltons. Using a standard single open-ended (SOE) AB sanitary style cartridge design, Ultipor VF Grade DV20 Virus Removal filters achieve practical flows and pressure drops in process-scale purification of biopharmaceuticals, tissue and plasma derivatives and protein additives. Where required, suitable prefilters employing the same PVDF membrane material are available, simplifying process optimization and filtration system validation.
Features and Benefits
- Sanitary direct flow cartridges
- Robust size exclusion mechanism
- ≥ 3 log TR for > 20 nm viruses
- ≥ 6 log TR for > 50 nm viruses
- Low binding for high protein yields
- High transmission of albumin and IgG
- Very low extractables
- Autoclavable and Steamable in situ (SIP)
- 100% integrity-tested (correlated to virus retention)
- Manufactured for use in conformance with cGMP
- Pharmaceutical P optimized with Certificate of Test provided
Claims are based on challenges with bacteriophage (bacterial viruses) PP7 (25 nm) and PR772 (53 nm) in 1% Bovine Serum Albumin in phosphate-buffered saline at pH 7.4, 20 °C (68 °F).
Quality and Bio-Safety Biological Tests
Integrity
- Every DV20 grade filter integrity tested during manufacture. Test correlated to viral (phage) removal
Biological Tests
- Meets USP Biological Reactivity Test, in vivo, for Class VI-121 °C Plastics
Effluent Quality Tests¹
- Meet 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
Autoclave Resistance
- Lot samples multi-cycle autoclave challenged
¹ Per lot sample or rinse-flush aliquots
Published Articles
Poster: Scalability of Ultipor® VF DV20 and UDV20 Virus Removal Cartridges (PDF, 100 kb)Specifications
Materials Of Construction
| Membrane | Hydrophilic modified polyvinylidenefluoride (PVDF) |
| Support and Drainage | Polyester |
| Core, Cage and End Caps | Polypropylene |
| Code 7 Adapter | Polypropylene with encapsulated stainless steel reinforcing ring |
| O-rings | Silicone |
Configuration
| Polypropylene with encapsulated stainless steel reinforcing ring |
Nominal Dimensions
| Length | 10 in. (254 mm), 20 in. (508 mm), 30 in. (762 mm), 40 in. (1016 mm) |
| Diameter | 70 mm (2.75 in.) |
Operating Conditions
| Recommended Operating ∆P | 1 – 2 bard (15 – 29 psid) |
| Maximum Differential Pressures | 6.0 bard (90 psid) during integrity testing 3.1 bard (45 psid) for continuous service |
Nominal Filter Area
| 1.0 m² (10.8 ft²) per 10 in. (254 mm) element |
Aqueous Extractables (NVR)
| < 5 mg per 10 in. (254 mm) element in deionized water at 20 °C (68 °F), process-ready (after integrity testing in 30% IPA/water, water flush and autoclaving) |
Autoclave and Steaming In Situ¹
| Maximum Temperature 125 °C (257 °F) |
¹ Contact Pall for recommended procedures to qualify filters under actual conditions of use
Typical Liquid Flow Rate²
| 15 L/h/10 in. (254 mm) module at 30 psid for 1% Bovine Serum Albumin in phosphate-buffered saline at pH 7.4, 20 °C (68 °F) |
² Claims based on challenges with bacteriophage (bacterial viruses) PP7 (25 nm) and PR772 (53 nm) in 1% Bovine Serum Albumin in phosphate-buffered saline at pH 7.4, 20 °C (68 °F)
Removal Ratings
| 3 Log TR for viruses > 20 nm 6 Log TR for viruses > 50 nm |
