Pall Mini Kleenpak™ Capsules with Pegasus™ Prime Virus Removal Filter Membrane product photo Primary L

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

Simple Tools for Scale-Up Confirmation

Pall Pegasus Prime virus membrane provides robust virus retention to protect critical manufacturing bioprocesses, assure drug quality and safeguard health. These gamma irradiated filters combine high flow and robust capacity, to simplify your process and deliver sustainable economy at all scales.

Filter performance can be established and scaled to products for clinical production using the same Pegasus Prime media as installed in Microdisc capsule formats (USD 3141). During pre-clinical process development it may be desirable to confirm the predicted throughout and flowrate using a larger, pleated format device as the available process volumes increase.

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.

Features and Benefits

 
Part of a full scale-up range with identical membrane at all scales* Reliable scalability
  • Meaningful process prediction to minimize oversizing of large-scale virus filtration
Gamma-irradiated Ready to use
  • No need for additional sterilization or sanitization procedures
Triclamp connectivity Easy to use
  • Easy connection to pre-filtration capsules
Small 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


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Capsules

List Price
$ 963.50
Description

Simple Tools for Scale-Up Confirmation

Pall Pegasus Prime virus membrane provides robust virus retention to protect critical manufacturing bioprocesses, assure drug quality and safeguard health. These gamma irradiated filters combine high flow and robust capacity, to simplify your process and deliver sustainable economy at all scales.

Filter performance can be established and scaled to products for clinical production using the same Pegasus Prime media as installed in Microdisc capsule formats (USD 3141). During pre-clinical process development it may be desirable to confirm the predicted throughout and flowrate using a larger, pleated format device as the available process volumes increase.

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.

Features and Benefits

 
Part of a full scale-up range with identical membrane at all scales* Reliable scalability
  • Meaningful process prediction to minimize oversizing of large-scale virus filtration
Gamma-irradiated Ready to use
  • No need for additional sterilization or sanitization procedures
Triclamp connectivity Easy to use
  • Easy connection to pre-filtration capsules
Small 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
Specifications
Materials of Construction
Filter Membrane: Polyethersulfone
Support and Drainage: Polyester
Capsule 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 °C
Maximum 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

Sterilization
Gamma >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 Type
13 mm (½ in.) sanitary flange inlet and outlet
Performance

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.

Figure 1
Robust scaling

Polyclonal IgG at 50% flux decay; n≥9 from 3 different lots
Ordering Information
 
Part Number Description Pkg
KA02PRM8FT Pall Mini Kleenpak Filterability Tool with Pegasus Prime Virus Removal Filter Membrane. Supplied sterile. 3/pkg
 

OPTIONAL - Pegasus Protect Prefilter

 
KA1PRTP18FT Pall Kleenpak Capsule with Pegasus Protect prefiltration media with 1 in. triclamp inlet and ½ in. triclamp outlet for direct connection to KA02PRM8FT. Supplied non-sterile. 1/pkg
 

Scale-down devices

 
3MCFPRM4 Pall Microdisc Capsules with Pegasus Prime Virus Removal Filter Membrane 4/box
3MCFPRM12 Pall Microdisc Capsules with Pegasus Prime Virus Removal Filter Membrane 12/box
(4 x 3 lots)
 

Scale-up - Clinical Scale Filters

 
AB1UPRM7PH4 Pall 254 mm (10 in.) filter cartridge with Pegasus Prime virus removal membrane. Nominal area 1 m2 1/pkg
N*6LUPRMP1S Pall 254 mm (10 in.) Kleenpak Nova filter capsule with Pegasus Prime virus removal membrane. Nominal area 1 m2 1/pkg
AB2UPRM7PH4 Pall 508 mm (20 in.) filter cartridge with Pegasus Prime virus removal membrane. Nominal area 2 m2 1/pkg
N*7LUPRMP1S Pall 508 mm (20 in.) Kleenpak Nova filter capsule with Pegasus Prime virus removal membrane. Nominal area 2 m2 1/pkg
AB3UPRM7PH4 Pall 762 mm (30 in.) filter cartridge with Pegasus Prime virus removal membrane. Nominal area 3 m2 1/pkg
N*8LUPRMP1S Pall 762 mm (30 in.) Kleenpak Nova filter capsule with Pegasus Prime virus removal membrane. Nominal area 3 m2 1/pkg
 
* [P] – In-line flow / [T] - T-style flow