Fluorodyne® EX EDF Membrane in Mini Kleenpak™ Syringe Filters product photo Primary L

Fluorodyne® EX EDF Membrane in Mini Kleenpak™ Syringe Filters

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 syringe filter capsules are designed for use in the laboratory. Featuring the lowest surface area in Pall’s UpScale and a very small hold-up volume, they are ideal for filtering the smallest quantities of fluids (up to 100 mL) with minimal losses.


Key Features and Benefits

  • Ideal for screening trials
  • Built-in, MachV asymmetric prefilter layer for long-life and low filtration costs
  • Low protein and preservative binding
  • Low extractables
  • Supplied pre-sterilized using gamma irradiation

Quality Standards

  • Meet USP Biological reactivity tests in-vivo in accordance with USP Class VI 121 °C for Biological safety
  • Endotoxin Level < 0.25 EU/mL using Limulus Amoebocyte Lysate (LAL) test
  • Cleanliness per USP Particulates in injectables
  • Non fiber releasing per CFR 211.72 and CFR 210.3(b)(6)

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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Fluorodyne® EX EDF membrane in Mini Kleenpak™ syringe filter capsules, 0.2 µm removal rating, 2.8 cm² EFA, pre-sterilized by gamma irradiation, box of 50 product photo

Fluorodyne® EX EDF membrane in Mini Kleenpak™ syringe filter capsules, 0.2 µm removal rating, 2.8 cm² EFA, pre-sterilized by gamma irradiation, box of 50

Product ID: KM2EDFS
Unit of Measure
1/PAC
Min Order Qty
1
Maximum Batch Volume
0.1 L
Effective Filtration Area (Metric)
2.8 cm²
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Documents

Datasheets

Download: English

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 syringe filter capsules are designed for use in the laboratory. Featuring the lowest surface area in Pall’s UpScale and a very small hold-up volume, they are ideal for filtering the smallest quantities of fluids (up to 100 mL) with minimal losses.


Key Features and Benefits

  • Ideal for screening trials
  • Built-in, MachV asymmetric prefilter layer for long-life and low filtration costs
  • Low protein and preservative binding
  • Low extractables
  • Supplied pre-sterilized using gamma irradiation

Quality Standards

  • Meet USP Biological reactivity tests in-vivo in accordance with USP Class VI 121 °C for Biological safety
  • Endotoxin Level < 0.25 EU/mL using Limulus Amoebocyte Lysate (LAL) test
  • Cleanliness per USP Particulates in injectables
  • Non fiber releasing per CFR 211.72 and CFR 210.3(b)(6)

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
Sealing Technology Insert molding
 

Operating Parameters¹

 
Maximum Operating Temperature and Pressure 5.4 bar (80 psi) at 20 °C
2.1 bar (30 psi) at 60 °C
 
¹ In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction


Sterilization²

 
Pre-sterilized, subject to a minimum of 25 kGy of gamma irradiation
 
² Pre-sterilized Mini Kleenpak syringe filters must not be re-sterilized. Mini Kleenpak syringe filters must not be sterilized in-situ by passing steam under pressure

Typical Hold up Volume

 
< 100 μL 
 


Nominal Dimensions

 
Capsule Length 21 mm (0.8 in.)
Capsule Diameter 29 mm (1.2 in.)
 

Nominal Effective Filter Area (EFA)

 
2.8 cm² (0.43 in.²)
 


Connection

 
Female luer lock inlet, male slip luer outlet
 

Type

Syringe Filters

Use

Sterilizing-Grade Liquid Filtration

Ordering Information


 
Item Part Number
Mini Kleenpak™ Syringe Filters with Fluorodyne® EX EDF Membrane KM2EDFS*
 

* supplied as 1 box of 50 filters

Product Summary

Fluorodyne® EX EDF Membrane in Mini Kleenpak™ Syringe Filter is ideal for screening trials and challenging final bulk biological processing. Syringe filters are made for laboratory purposes and feature the lowest surface area in the Pall UpScale range. Their compact design also provides low hold up volumes for the ideal small quantity filtration experience. All filters are pre-sterilized with gamma radiation for sterility.

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