Pall Mini Kleenpak™ Capsules with Pegasus™ Prime Virus Removal Filter Membrane

Simple Tools for Scale-Up ConfirmationPegasus 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 Mini Kleenpak capsules containing Pegasus Prime virus media are optimized as a filterability tool suitable for the confirmation of performance during pre-clinical process development.

As shown in Figure 1, the filter sizing and process times confirmed during these studies then scale to a range of products available to support your process during clinical manufacture. Where required, these can then be integrated into single-use and automated solutions to offer the highest degree of control, flexibility and security.

USD3142a

2

Features and BenefitsPart of a full scale-up range with Reliable scalability identical membrane at all scales* •Meaningfulprocesspredictionto

minimize oversizing of large-scale virus filtration

Gamma-irradiated Ready to use •Noneedforadditionalsterilization

or sanitization proceduresTriclamp connectivity Easy to use •Easyconnectiontopre-filtration

capsulesSmall fill volume Economic process confirmation* Mini Kleenpak Capsule Filterability Tools are for filter-sizing studies and evaluation during process development only. They are not qualified for virus removal. Pall Corporation provides filters for use during drug manufacture or for animal, human therapeutic or diagnostic needs. Please contact Pall for details of filters where needed as Mini Kleenpak Capsule Filterability Tools are not intended for these purposes

Figure 1Robust scaling

• Polyclonal IgG at 50% flux decay; n≥9 from 3 different lots

SpecificationsMaterials of Construction Filter Membrane: PolyethersulfoneSupport and Drainage: PolyesterCapsule Shell, Core and Endcaps: Polypropylene

Retention Ratings** Pore size : 20 nm nominal Virus: > 4 log reduction value with mammalian parvoviruses Effective Filter Area (EFA) (Nominal)204 cm2 (31.6 in2)

Operating Parameters** Maximum Temperature: 38 °CMaximum Pressure: 3.1 bar (45 psi)***

Maximum Differential Pressure: 3.1 bar (45 psi)***** In compatible fluids which do not soften, swell or adversely affect

the filter or its materials of construction*** up to 12 hours at 25 °C; up to 6 hours at 38 °C

SterilizationGamma >25 kGy

Liquid Flow v Differential Pressure (Typical)123 mL/min at 2.1 bard (30 psid), water at 20 °C

Dimensions (Nominal) Maximum diameter including valves: 53 mm (2.1 in.)Length: 73 mm (2.9 in.)

Connection Type13 mm (½ in.) sanitary flange inlet and outlet

Ordering InformationPart Number Description Pkg

KA02PRM8FT PallMiniKleenpakFilterabilityToolwith 3/pkg PegasusPrimeVirusRemovalFilter Membrane.Suppliedgammairradiated.

Microdisc 2.8 cm2 10 inch

10,000 cm2

0% 20% 40% Microdisc Batch Time (%)

Bat

ch V

olum

e (%

)

60% 80% 100% 120%

100%

75%

50%

25%

0%

Mini Kleenpak204 cm2

Visit us on the Web at www.pall.com/biotechContact us at www.pall.com/contact

© 2020, Pall Corporation. Pall, , Kleenpak, and Pegasus are trademarks of Pall Corporation. ® indicates a trademark registered in the USA. TM indicates a common law trademark. Filtration.Separation.Solution. is a service mark of Pall Corporation.

7/20, PDF, GN20.07591 USD3142a

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The information provided in this literature was reviewed for accuracy at the time of publication. Product data may be subject to change without notice. For current information consult your local Pall distributor or contact Pall directly.