Pall Kleenpak™ Nova Capsules and Cartridges with Pegasus™ Prime Virus Removal Filter Membrane
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Pegasus™ Prime membrane in Kleenpak™ Nova capsule, 20 nm removal rating, in-line style, 1-inch capsule, 1 in. sanitary flange connections, pre-sterilized by gamma irradiation
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Pegasus™ Prime membrane in Kleenpak™ Nova capsule, 20 nm removal rating, T style, 10-inch capsule, 1 in. sanitary flange connections, pre-sterilized by gamma irradiation
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Pegasus™ Prime membrane in Kleenpak™ Nova capsule, 20 nm removal rating, in-line style, 10-inch capsule, 1 in. sanitary flange connections, pre-sterilized by gamma irradiation
1/EA
1
Pegasus™ Prime membrane in Kleenpak™ Nova capsule, 20 nm removal rating, in-line style, 5-inch capsule, 1 in. sanitary flange connections, pre-sterilized by gamma irradiation
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Documents
Datasheets
Download:Description
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
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| Robust capacity and high flow. | Small filtration footprints and short process times
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| Gamma-irradiated, sterile and fully disposable | Ready to use.
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| Full scale-up range | Predictable performance at all scales
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| Full pre-filter scale-up range with consistent pre-filter to virus filter area ratios |
Control scale-up risks
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| Water wet integrity testing | Easy to use
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Specifications
| 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 |
-- | 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 |
*
|
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| 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 |
| Connection Type | n/a | 1 in. sanitary flange inlet and outlet |
| Forward Flow Integrity Test | Water wet, diffusional flow integrity test |
Performance
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 1Robust, High Virus Retention
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.
Figure 2
Relative Virus Filter Sizing in Fluids With Varying Fouling Characteristics
Type
Use
Related Documents
Regulatory/Quality Documentation
Ordering Information
| 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 |
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