Fluorodyne® II DFL Membrane in Mini Kleenpak™ 20 Capsules product photo Primary L

Fluorodyne® II DFL Membrane in Mini Kleenpak™ 20 Capsules

These validated 0.2 micron-rated sterilizing grade filters retain Brevundimonas diminuta (ATCC 19146) at 107CFU/cm² effective filter area (EFA) and ensure very low extractables and adsorption. They are recommended for sterilizing filtration of pharmaceutical fluids including solutions with active ingredients, biologicals, biotech proteins, ophthalmics and other dilute preservative solutions.

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
  • Highest flow of  PVDF of comparable PVDF filters
  • 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 
  • 100% integrity tested
  • ISO 9000 Certified Quality System
  • Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
  • Every filter tested during manufacture
  • Test correlated to microbial retention
  • Certificate of Test provided includes
    • Fabrication Integrity 
    • Bacterial Retention 
    • Material of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens


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Capsules

Fluorodyne® II DFL membrane (0.2 µm removal rating) discs in Mini Kleenpak™ 20 capsules with ¼ to ½ inch hosebarb connections, pre-sterilized by gamma irradiation (box of 3)

Product ID: KM5DFLP2S
Unit of Measure
1/EA
Min Order Qty
1
Membrane Material
Polyvinylidene fluoride (PVDF)
Industry-Specific Certification
Pharmaceutical Grade
Effective Filtration Area (Metric)
20 cm²
Format
Mini Kleenpak 20
Inlet Connection
¼-½ in (6-13 mm) hose barb
Outlet Connection
¼-½ in (6-13 mm) hose barb
See All Attributes
$ 112.00
Description
These validated 0.2 micron-rated sterilizing grade filters retain Brevundimonas diminuta (ATCC 19146) at 107CFU/cm² effective filter area (EFA) and ensure very low extractables and adsorption. They are recommended for sterilizing filtration of pharmaceutical fluids including solutions with active ingredients, biologicals, biotech proteins, ophthalmics and other dilute preservative solutions.

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
  • Highest flow of  PVDF of comparable PVDF filters
  • 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 
  • 100% integrity tested
  • ISO 9000 Certified Quality System
  • Meets USP Biological Reactivity Test in vivo for Class VI-121 °C plastics
  • Every filter tested during manufacture
  • Test correlated to microbial retention
  • Certificate of Test provided includes
    • Fabrication Integrity 
    • Bacterial Retention 
    • Material of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens
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
 

Ordering Information

 
Item Part Number*
Mini Kleenpak™ 20 Capsules with Fluorodyne® II DFL Membrane KM5DFLP2S
 

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