Pegasus™ LV6 Virus Prefiltration product photo Primary L

Pegasus™ Grade LV6 Virus Removal Filter Cartridges

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


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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)
Application
Filters - Plasma and High-Fouling mAb
Segment
Viral Clearance