Description
Extending Virus Filter Capacity in the Most Challenging Feeds
Pegasus LV6 is a size-based prefilter delivering high flow and high capacity for aggregates in the nano meter range that would normally foul the virus filter.
Aggregates that foul virus filters come in different sizes and with different physiochemical properties. There are aggregates and/or conditions for which adsorption based pre filters fail and for which sized based prefiltration gives better performance in protecting and extending the life of the subsequent virus filter.
Pegasus LV6 membrane in combination with the patented Ultipleat® filter construction provides robust high flow rates and total throughput of both Pegasus LV6 and the subsequent virus filter, which minimizes process costs. The high filter area per filter cartridge reduces the required amount of filter elements per installation and also minimizes the total hold-up volume of the virus filter system by protecting the virus filter. The proven hydrophilic PVDF sub-microporous membrane enables high transmission of proteins.
Features and Benefits
- Improvement of subsequent virus filter throughput and flow
- Reducing virus filter sizing and cost
- High flow rate and total throughput performance
- High filter area per filter cartridge
- Reducing prefilter sizing
- Reducing total virus system hold-up volume
- Low binding and high transmission for high protein yields
- Prewetted for ease of use
- SIP and CIP compatible
High Quality Standards
- Manufactured in accordance with cGMP
- Certificate of Test
- Non-Fiber-Releasing per 21 CFR
- Biological Tests:
- Meets USP Biological Reactivity,in vivo, for Class VI-121 °C plastics
- Effluent Quality Tests (P tests):1
- Meets Cleanliness per USP Particulates in Injectables
- Non-Pyrogenic per USP Bacterial Endotoxins (< 0.25 EU/mL)
- Meets Total Organic Carbon and Conductivity per USP Purified Water, pH per USP packaged waters
1 Confirmed for each filter lot
Specifications
Materials Of Construction
| Membrane | Acrylate-modified polyvinylidene fluoride (PVDF) |
| Membrane Support and Drainage Layers | Polyethylene/polypropylene |
| Core and Endcaps | Polypropylene |
| Filter Cage | Polypropylene with encapsulated reinforcing ring |
| O-rings | Ethylene propylene |
Operating Conditions
| Recommended Operating Differential Pressure | 1 – 2 bar (14.5 – 29 psi differential) |
| Maximum Differential Pressure |
4.1 bar (60 psi) during integrity testing 3.1 bar (45 psi) for continuous service 0.3 bar (5 psi) during steam sterilization |
Autoclave/Steaming¹
| Autoclavable or steamable in-situ for up to 3 cycles | Maximum Temperature 125 °C |
¹ Contact Pall for recommended procedures to qualify filters under actual conditions of use.
Typical Aqueous Extractables (NVR)
| Out of Box, T0 | Average 32 mg, Standard Deviation 3.6 mg |
| After autoclaving at 125 °C ± 5 °C | Average 56 mg, Standard Deviation 3.6 mg |
Filter Area (Nominal)
| 1.65 m² (17.8 ft²) per 254 mm (10 in.) element | |
Flow Rate/Differential Pressure
| 12 L/min per 254 mm (10 in.) module Water Flow Rate at 2.1 bar (30 psi) differential pressure |
Process Scale-up with Pegasus Grade LV6 Virus Filters
| Part Number | Filter Area |
| FTKLV6047025 – Box of 25 Filter Disks | 11.1 cm² (0.012 ft²) |
| FTKLV604705 – Box of 5 Filter Disks | |
| AB( )ULV67PJ | 1.65 m (17.8 ft²) per 254 mm (10 in.) |
Length Code: 1 = 254 mm (10 in.), 2 = 508 mm (20 in.), 3 = 762 mm (30 in.)
Other Pall Direct Flow Virus Filters and Prefilters with Hydrophilic PVDF membrane
| Membrane Type | Description |
| UDV50 | > 6 Log TR for viruses > 50 nm |
| DV20 | > 3 Log TR for viruses > 20 nm |
| DVD | Sub 0.1 μm virus prefilter |
| DJL | 0.1 μm (+ 0.2 μm prefilter layer) |
| DFL | 0.2 μm (double-layer) |
| DBL | 0.45 μm (+ 0.65 μm prefilter layer) |
