Fluorodyne® II DFL Filters product photo Primary L

Fluorodyne® II DFL Filters

These validated 0.2 micron-rated sterilizing grade filters retain Brevundimonas diminuta (ATCC 19146) at 107 CFU/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.
 
Pall’s standard AB-style filters are replaceable cartridges used with stainless steel housing assemblies, suitable for medium-to-large-scale manufacturing operations (100 L to > 1000 L), featuring 226 O-rings as standard. These cartridges are also available encapsulated in the Kleenpak™ Nova capsule format.

Features

  • 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

  • 100% integrity tested
  • 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 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


* Required
Description
These validated 0.2 micron-rated sterilizing grade filters retain Brevundimonas diminuta (ATCC 19146) at 107 CFU/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.
 
Pall’s standard AB-style filters are replaceable cartridges used with stainless steel housing assemblies, suitable for medium-to-large-scale manufacturing operations (100 L to > 1000 L), featuring 226 O-rings as standard. These cartridges are also available encapsulated in the Kleenpak™ Nova capsule format.

Features

  • 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

  • 100% integrity tested
  • 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 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
Specifications

Materials of Construction

 
 Filter Membrane  Hydrophilic modified PVDF
 Support/Drainage  Polypropylene
 Core/End Caps  Polypropylene
 Cage  Polypropylene with TiO2 whitener¹
 O-rings  Silicone elastomer
 Sealing Technology  Thermal bonding without adhesives
 
¹ TiO2 is an insoluble inorganic mineral filler that does not contribute to organic extractables

Operating Parameters²

 
 Maximum Temperature 80 ºC
 Maximum Differential Pressure (Forward Direction) 5.3 bar (77 psi) at 50 °C
3.4 bar (49 psi) at 80 °C
 Maximum Differential Pressure (Reverse Direction) 0.3 bar (4 psi)
 
² In compatible fluids which do not soften, swell, or adversely affect the filter or its materials of construction. DFL filter media may be used at 90 ºC. Contact Pall for further details

Sterilization

 
 Autoclave and In Situ Steam 30 x 60 minutes at 125°C
10 x 60 minutes at 140°C
 

Typical Extractables in Water at 20 °C³

 
 < 5 mg per 254 mm (10 in.) cartridge
 
³  Tested on elements without pre-flushing

Nominal Effective Filter Area (EFA)

 
 5500 cm² (5.9 ft²) per 254 mm (10 in.) cartridge
 

Integrity Test Values (Air test gas, water wet)*

 
Max. allowable forward flow values
for 254 mm (10 in.) cartridge at 20°C
 12  mL/min at 2760 mbar (40 psi)
 
* Contact Pall for multi-element integrity test values and recommended test procedures

membrane filter, membrane filters

Ordering Information
 
Item Part Number
Fluorodyne® II DFL Membrane Filter Cartridge
0.2 micron sterilizing grade, nominal length 125 mm (5 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin
 AB05DFL7PH4
Fluorodyne® II DFL Membrane Filter Cartridge
0.2 micron sterilizing grade, nominal length 125 mm (5 in.); Pall Code 2 double O-ring (silicone elastomer), bayonet lock, no fin
AB05DFL2PH4
Fluorodyne® II DFL Membrane Filter Cartridge
0.2 micron sterilizing grade, nominal length 254 mm (10 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin
AB1DFL7PH4
Fluorodyne® II DFL Membrane Filter Cartridge
0.2 micron sterilizing grade, nominal length 508 mm (20 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin
AB2DFL7PH4
Fluorodyne® II DFL Membrane Filter Cartridge
0.2 micron sterilizing grade, nominal length 762 mm (30 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin
AB3DFL7PH4
 
Application
Filters - Liquid - Sterile (0.2 micron)
Segment
Filtration