Fluorodyne® EX EDF - Kleenpak™ Capsules product photo Primary L

Fluorodyne® EX EDF - Kleenpak™ Capsules

Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 107 cfu/ cm2 of membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids.

Kleenpak capsules with Fluorodyne EX grade EDF membrane are rugged and compact, and are designed for use in pharmaceutical manufacturing and pilot scale filter evaluation.

Further Reading

 Poster: Scale Up of Direct Flow Membrane Filters

 Article: Bacterial Penetration of 0.2 μm Sterilizing-Grade Filters with a Cholesterol Liposome Carrier: A Comparison of Data



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Description
Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 107 cfu/ cm2 of membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids.

Kleenpak capsules with Fluorodyne EX grade EDF membrane are rugged and compact, and are designed for use in pharmaceutical manufacturing and pilot scale filter evaluation.

Further Reading

 Poster: Scale Up of Direct Flow Membrane Filters

 Article: Bacterial Penetration of 0.2 μm Sterilizing-Grade Filters with a Cholesterol Liposome Carrier: A Comparison of Data

Specifications

Materials Of Construction

 
Filter Membrane Prefilter Layer: Hydrophilic asymmetric PES
Final Filter Layer: Hydrophilic PVDF

Support/Drainage
End Cap, Core and Cage
Capsule Shell

Polypropylene
Polypropylene
Polypropylene
Sealing Technology Thermal bonding without adhesives
 

Operating Parameters¹

 
Maximum Operating Temperature  40 °C 
Maximum Operating Pressure 5.2 bar (75 psi) at 20 °C
4.0 bar (58 psi) at 40 °C
Maximum Differential Pressure 4.0 bar (58 psi) at 40 °C
 
¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction


Sterilization²

 
Autoclave (G option only)  5 x 60 minutes at 125 °C
Gamma Irradiation (G option only) Maximum of 50 kGy
 
² Pre-sterilized Kleenpak capsules must not be re-sterilized. Kleenpak capsules must not be sterilized in-situ by passing steam under pressure

Typical Extractables in Water at 20 °C

 
< 10 mg per capsule
 


Nominal Dimensions

 
Capsule Length 157 mm (6.2 in.)
Capsule Diameter including valves 94 mm (3.7 in.)
 

Nominal Effective Filter Area (EFA)

 
750 cm² (0.8 ft²)
 


Ordering Information
 
Item Part Number
Kleenpak™ Capsule with Fluorodyne® EX Grade EDF Membrane
1½ in. sanitary flange, non-sterile, gamma irradiatable/autoclavable
KA2EDFP1G
Kleenpak™ Capsule with Fluorodyne® EX Grade EDF Membrane
1½ in. sanitary flange, pre-sterilized using gamma irradiation
KA2EDFP1S
 
Application
Filters - Liquid - Sterile (0.2 micron)
Segment
Filtration