Pall Kleenpak™ Nova Capsules and Cartridges with Pegasus™ Prime Virus Removal Filter Membrane product photo Primary L

Pall Kleenpak™ Nova Capsules and Cartridges with Pegasus™ Prime Virus Removal Filter Membrane

Process-Scale Virus Filtration

Pegasus Protect virus prefiltration combines with Pegasus Prime virus filtration to deliver the first gamma-sterilized pre-filter & virus filter combination. Together, these simplify process development, validation and operations while saving time and delivering improved process economy.

Process developers can quickly deliver a robust, scalable virus filtration process using a minimum of sample volume, and be confident of successful virus validation. This choice supports clinical manufacturing with a solution that is easy to use and versatile to work alone or with integrated and automated single-use systems.

The flow, filter capacity and virus retention established during small scale filterability and virus validation studies scale to a range of products to support your process and offer the highest degree of manufacturing control, flexibility and security.

Features and Benefits

Robust high LRV, independent of Robust high LRV, independent of Stable performance and
assured process fluid or process parameters
Stable performance and assured patient safety in a broad process design space
  • Maximize process flexibility to minimize the risk of process deviations
Robust capacity and high flow. Small filtration footprints and short process times
  • Economic processes and easy integration into automated processes
Gamma-irradiated, sterile and fully disposable Ready to use.
  • No need for additional sterilisation or sanitisation procedures
Full scale-up range Predictable performance at all scales
  • Simple process development
Full pre-filter scale-up range with consistent pre-filter to virus filter area
ratios
Control scale-up risks
  • Faster, simplified scale-up
Water wet integrity testing Easy to use
  • As simple to use as sterile filtration


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설명

Process-Scale Virus Filtration

Pegasus Protect virus prefiltration combines with Pegasus Prime virus filtration to deliver the first gamma-sterilized pre-filter & virus filter combination. Together, these simplify process development, validation and operations while saving time and delivering improved process economy.

Process developers can quickly deliver a robust, scalable virus filtration process using a minimum of sample volume, and be confident of successful virus validation. This choice supports clinical manufacturing with a solution that is easy to use and versatile to work alone or with integrated and automated single-use systems.

The flow, filter capacity and virus retention established during small scale filterability and virus validation studies scale to a range of products to support your process and offer the highest degree of manufacturing control, flexibility and security.

Features and Benefits

Robust high LRV, independent of Robust high LRV, independent of Stable performance and
assured process fluid or process parameters
Stable performance and assured patient safety in a broad process design space
  • Maximize process flexibility to minimize the risk of process deviations
Robust capacity and high flow. Small filtration footprints and short process times
  • Economic processes and easy integration into automated processes
Gamma-irradiated, sterile and fully disposable Ready to use.
  • No need for additional sterilisation or sanitisation procedures
Full scale-up range Predictable performance at all scales
  • Simple process development
Full pre-filter scale-up range with consistent pre-filter to virus filter area
ratios
Control scale-up risks
  • Faster, simplified scale-up
Water wet integrity testing Easy to use
  • As simple to use as sterile filtration

규격사양

Materials of Construction Filter Cartridges Kleenpak Nova Capsules
Filter Membrane Polyethersulfone Polyethersulfone
Support and Drainage Polyester Polyester
Endcap and adaptor Polypropylene Polypropylene
Core and cage Polypropylene Polypropylene
O-rings Silicone elastomer Silicone elastomer
Capsule hardware -- Polypropylene
Valve seals -- Silicone elastomer


Retention Ratings
Pore size 20 nm (nominal)
Virus > 4 log reduction value for mammalian parvoviruses


Effective Filter Area (EFA) (Nominal) 1 m2 (10.7 ft2) per 10 in.


Operating Parameters*
Maximum Temperature 40 °C 40 °C
Maximum Pressure - 5.4 bar (76 psi) at 20 °C
3.0 bar (43.5 psi) at 40 °C
Maximum Differential Pressure 4.15 bar (60 psi) 4.15 bar (60 psi)


Recommended Operating Conditions 2.1 to 3.1 bard (30 to 45 psid)


Sterilization Supplied sterile (irradiated at > 25kGy)


Shelf Life 3 years
* In compatible fluids that do not soften or swell, or adversely affect the filter or its materials of construction. Contact Pall for recommended procedures to qualify filters under actual conditions of use


Aqueous Extractables (NVR) Refer to Pall Publication USTR3143


Dimensions (Nominal) Filter Cartridges Kleenpak Nova Capsules In-Line
Length --
--
254 mm (10 in.)
508 mm (20 in.)
762 mm (30 in.)
128 mm (5.1 in.)
213 mm (8.4 in.)
335 mm (13.2 in.)
584 mm (23.0 in.)
834 mm (32.8 in.)
Diameter including valves n/a 154 mm (6.1 in.)
Connection Type n/a 1 in. sanitary flange intet and outlet


Connection Type n/a 1 in. sanitary flange inlet and outlet


Forward Flow Integrity Test Water wet, diffusional flow integrity test

성능

Pegasus Prime virus filters deliver robust, high LRV independent of process parameters, process fluid and validation choices.

The data illustrated in Figure 1 demonstrate the reliable and stable performance across a wide range of process conditions and highlights process flexibility that makes Pegasus Prime virus filtration the ideal first choice virus filter for bioprocesses.

Figure 1
Robust, High Virus Retention
graph1

1 Tested using phage PP7
2 Tested using phage ϕX174

Pegasus Prime virus filters combine high LRV with high throughput and high flow in all mAb solutions to deliver an economic virus filtration solution with a small footprint for easy integration into single-use and automated processes.

The performance of three virus filtration options in a variety of fouling fluids is shown in Figure 2. These data illustrate that Pall’s comprehensive virus filtration portfolio can minimize the number of virus filters required for any given process. The most common economic solutions are shown below.


arrow1

Figure 2
Relative Virus Filter Sizing in Fluids With Varying Fouling Characteristics

종류

Filter Capsules

사용

Viral Safety

주문정보

Part Number Description Filter Area Pkg
NP1LUPRMP1S 1 in. Kleenpak Nova Capsule (In-Line Style) 0.1 m2 1/pkg
NP5LUPRMP1S 5 in. Kleenpak Nova Capsule (In-Line Style) 0.5 m2 1/pkg
AB1UPRM7PH4S 10 in. Filter Cartridge 1 m2 1/pkg
NP6LUPRMP1S 10 in. Kleenpak Nova Capsule (In-Line Style) 1 m2 1/pkg
NT6UPRMP1S 10 in. Kleenpak Nova Capsule (T-Style) 1 m2 1/pkg
AB2UPRM7PH4S 20 in. Filter Cartridge 2 m2 1/pkg
NP7LUPRMP1S 20 in. Kleenpak Nova Capsule(In-Line Style) 2 m2 1/pkg
NT7UPRMP1S 20 in. Kleenpak Nova Capsule(T-Style) 2 m2 1/pkg
AB3UPRM7PH4S 30 in. Filter Cartridge 3 m2 1/pkg
NP8LUPRMP1S 30 in. Kleenpak Nova Capsule(In-Line Style) 3 m2 1/pkg
NT8UPRMP1S 30 in. Kleenpak Nova Capsule (T-Style) 3 m2 1/pkg