Fluorodyne® EX EDF Membrane in Mini Kleenpak™ 20 Capsules product photo Primary L

Fluorodyne® EX EDF Membrane in Mini Kleenpak™ 20 Capsules

Fluorodyne EX grade EDF filters are high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain Brevundimonas diminuta (ATCC 19146) at a concentration of 107 CFU/cm², Fluorodyne EX EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids.

Mini Kleenpak 20 capsules are suited to both the filtration of low volumes of fluids (50 mL to 2 L) in the laboratory for filterability purposes, or in a GMP production environment where a certified filter product is essential and a single-use alternative to the cleaning of 47 mm disc holders is desired.


Key Features and Benefits

  • Ideal for screening trials
  • Asymmetric built-in prefilter for higher dirt-holding capacity
  • Low protein and preservative binding
  • Low extractables

Quality Standards

  • Manufactured for use in conformance with cGMP
  • ISO 9000 Certified Quality System 
  • Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
  • Every filter lot tested during manufacture
  • Test correlated to microbial retention
  • Certificate of Test provided includes:
    • Fabrication Integrity
    • Bacterial Retention
    • Materials of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens

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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Capsules

List Price
$ 141.00
Description
Fluorodyne EX grade EDF filters are high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain Brevundimonas diminuta (ATCC 19146) at a concentration of 107 CFU/cm², Fluorodyne EX EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids.

Mini Kleenpak 20 capsules are suited to both the filtration of low volumes of fluids (50 mL to 2 L) in the laboratory for filterability purposes, or in a GMP production environment where a certified filter product is essential and a single-use alternative to the cleaning of 47 mm disc holders is desired.


Key Features and Benefits

  • Ideal for screening trials
  • Asymmetric built-in prefilter for higher dirt-holding capacity
  • Low protein and preservative binding
  • Low extractables

Quality Standards

  • Manufactured for use in conformance with cGMP
  • ISO 9000 Certified Quality System 
  • Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
  • Every filter lot tested during manufacture
  • Test correlated to microbial retention
  • Certificate of Test provided includes:
    • Fabrication Integrity
    • Bacterial Retention
    • Materials of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens

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
Housing, Vent Plug and Support Material Polypropylene (Filling Bell is polycarbonate)
Sealing Technology Thermal bonding without adhesives
 

Operating Parameters ¹ ²

 
Maximum Operating Temperature and Pressure 1.4 bar (20 psi) at 20 °C
 
¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction
² For continuous operation. May be exceeded during Bubble Point integrity testing. Please contact Pall for further details


Sterilization³

 
Pre-sterilized, subject to a minimum of 25 kGy of gamma irradiation
 
³ Pre-sterilized Mini Kleenpak 20 capsules must not be re-sterilized. Mini Kleenpak 20 capsules must not be sterilized in-situ by passing steam under pressure

Typical Hold up Volume

 
< 2.5 mL 
 


Nominal Dimensions

 
Capsule Length 83 mm (3.3 in.)
Capsule Diameter 67 mm (2.7 in.)
 

Nominal Effective Filter Area (EFA)

 
20 cm² (3.1 in.²)
 


Connection

 
¼ – ½ in. (6 – 13 mm) stepped hose barb. Inner bore to accept female slip luer interior and outer diameter to accept filling bell outlet
 

Ordering Information

 
Item Part Number*
Mini Kleenpak™ 20 Capsules with Fluorodyne® EX EDF Membrane KM5EDFP2S
 

* supplied as 1 box of 3 filters
Application
Filters - Liquid - Sterile (0.2 micron)