Fluorodyne® II DJL - Mini Kleenpak™ 20 Capsules product photo Primary L

Fluorodyne® II DJL - Mini Kleenpak™ 20 Capsules

These 0.1 micron-rated filters with serial layer (0.2/0.1 micron) membrane construction assure high flow rates compared with other 0.1 micron (and even some 0.2 micron)-rated filters. Fluorodyne II grade DJL filters are validated for removal of Acholeplasma laidlawii mycoplasma (ATCC 28206) with a typical TR >1011 and retention of Brevundimonas diminuta (ATCC 19146) at 107CFU/cm² effective filter area (EFA). This allows for enhanced sterilization assurance as well as efficient mycoplasma control.

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

  • Highest flow of PVDF compared to other 0.1 µm filters
  • Built in prefiltration layer 
  • High safety for A. laidlawii 
  • Sterilizing grade claim
  • Low extractables  
  • High protein transmission
  • Rapid preservative recoveries 
  • Easy integrity testing 
  • Compatible with organic solvents, acids and chemicals¹
  • Resin and surfactant-free 
  • Melt-sealed, non shedding
    ¹ Except ketones and amides

Quality Standards

  • Manufactured for use in conformance with cGMP 
  • Integrity tested at manufacture
  • ISO 9000 Certified Quality System
  • Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
  • Test correlated to microbial retention
  • Certificate of Test provided includes
    • Fabrication Integrity 
    • Bacterial Retention 
    • Material of Construction
    • Effluent quality for cleanliness and endotoxins


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Format

Mini Kleenpak 20

Inlet Configuration

¼-½ in (6-13 mm) hose barb

Fluorodyne® II DJL membrane discs in Mini Kleenpak™ 20 capsules, 0.1 µm removal rating, 20 cm² EFA, ¼-½ in. hose barb connections, pre-sterilized by gamma irradiation, box of 3 product photo

Fluorodyne® II DJL membrane discs in Mini Kleenpak™ 20 capsules, 0.1 µm removal rating, 20 cm² EFA, ¼-½ in. hose barb connections, pre-sterilized by gamma irradiation, box of 3

Product ID: KM5DJLP2S
Unit of Measure
1/EA
Min Order Qty
1
Removal Rating
0.1 µm
Membrane Material
Polyvinylidene fluoride (PVDF)
Effective Filtration Area (Metric)
20 cm²
See All Attributes

Description

These 0.1 micron-rated filters with serial layer (0.2/0.1 micron) membrane construction assure high flow rates compared with other 0.1 micron (and even some 0.2 micron)-rated filters. Fluorodyne II grade DJL filters are validated for removal of Acholeplasma laidlawii mycoplasma (ATCC 28206) with a typical TR >1011 and retention of Brevundimonas diminuta (ATCC 19146) at 107CFU/cm² effective filter area (EFA). This allows for enhanced sterilization assurance as well as efficient mycoplasma control.

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

  • Highest flow of PVDF compared to other 0.1 µm filters
  • Built in prefiltration layer 
  • High safety for A. laidlawii 
  • Sterilizing grade claim
  • Low extractables  
  • High protein transmission
  • Rapid preservative recoveries 
  • Easy integrity testing 
  • Compatible with organic solvents, acids and chemicals¹
  • Resin and surfactant-free 
  • Melt-sealed, non shedding
    ¹ Except ketones and amides

Quality Standards

  • Manufactured for use in conformance with cGMP 
  • Integrity tested at manufacture
  • ISO 9000 Certified Quality System
  • Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
  • Test correlated to microbial retention
  • Certificate of Test provided includes
    • Fabrication Integrity 
    • Bacterial Retention 
    • Material of Construction
    • Effluent quality for cleanliness and endotoxins

Specifications

Materials Of Construction

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

Operating Parameters¹

 
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


Sterilization²

 
Pre-sterilized, subject to a minimum of 25 kGy of gamma irradiation
 
² 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
 

Type

Filter Capsules

Use

Mycoplasma Removal

Ordering Information

 
Item Part Number*
Mini Kleenpak™ 20 Capsules with Fluorodyne® II DJL Membrane KM5DJLP2S
 

* supplied as 1 box of 3 filters

Product Summary

Fluorodyne® II DJL Membrane in Mini Kleenpak™ 20 Capsules are compatible with organic solvents, acids and chemicals. They are integrity tested and manufactured to USP Biological Reactivity Test standards. DJL produces high rates of microbial retention and protein transmission. Efficient for A. laidlawii and other organism filtration. DJL has the highest flow of PVDF for compatible filters of its size.

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