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Fluorodyne® II DJL Cartridges

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 23206) with a typical TR >108 and retention of Brevundimonas diminuta (ATCC 19146) at 107 CFU/cm² effective filter area (EFA). This allows for enhanced sterilization assurance as well as efficient mycoplasma control.

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). With Code 7 fittings as standard, these cartridges are the most versatile filtration units in Pall’s product range, and are available with a broader range of filtration media than any other filter type. These cartridges are also available encapsulated in the Kleenpak™ Nova capsule format.

Key Features and Benefits

  • 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
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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 23206) with a typical TR >108 and retention of Brevundimonas diminuta (ATCC 19146) at 107 CFU/cm² effective filter area (EFA). This allows for enhanced sterilization assurance as well as efficient mycoplasma control.

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). With Code 7 fittings as standard, these cartridges are the most versatile filtration units in Pall’s product range, and are available with a broader range of filtration media than any other filter type. These cartridges are also available encapsulated in the Kleenpak™ Nova capsule format.

Key Features and Benefits

  • 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 (50 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

Sterilization

 
 Autoclave and In Situ Steam 30 x 60 minutes at 125°C
5 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		  29  mL/min at 4475 mbar (65 psi)
 
* Contact Pall for multi-element integrity test values and recommended test procedures

Typical Liquid Flow vs. Differential Pressure

Type

Filter Cartridges

Use

Mycoplasma Removal

Ordering Information

 
Item Part Number
Fluorodyne® II DJL Membrane Filter Cartridge
0.1 micron sterilizing grade and mycoplasma control, nominal length 125 mm (5 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin		  AB05DJL7PH4
Fluorodyne® II DJL Membrane Filter Cartridge
0.1 micron sterilizing grade and mycoplasma control, nominal length 125 mm (5 in.); Pall Code 2 double O-ring (silicone elastomer), bayonet lock, no fin		 AB05DJL2PH4
Fluorodyne® II DJL Membrane Filter Cartridge
0.1 micron sterilizing grade and mycoplasma control, nominal length 254 mm (10 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin		 AB1DJL7PH4
Fluorodyne® II DJL Membrane Filter Cartridge
0.1 micron sterilizing grade and mycoplasma control, nominal length 508 mm (20 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin		 AB2DJL7PH4
Fluorodyne® II DJL Membrane Filter Cartridge
0.1 micron sterilizing grade and mycoplasma control, nominal length 762 mm (30 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin		 AB3DJL7PH4
 

 

Product Summary

Fluorodyne® II DJL Membrane Filter Cartridges are AB-style, replaceable cartidges suited for medium to large scale production. Filters are resin free and melt-sealed for guaranteed contamination prevention. The filter design is ideal for high retention of mycoplasma and high flow rates. Each filter is integrity tested and meets USP Biological Reactivity Test standards.

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