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Fluorodyne® EX EDF Cartridges

Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 107 cfu/ cm2 of membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids.

Pall's 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), supplied with -226 O-ring (Pall code 2 or code 7) fittings as standard.

AB-style filters with Fluorodyne EX grade EDF membrane feature a laid over pleat membrane construction and high effective filtration area (>1 m2 per 10” assembly) for outstanding throughput performance.

A validation package for Fluorodyne EX grade EDF filters supports the assurance of safety within your process.

Key Features and Benefits

  • Laid-over pleat filter construction allows for high flow rates and smaller filtration systems
  • Narrow core design for more area
  • Asymmetric built-in prefilter layer for higher dirt-holding capacity
  • Low protein and preservative binding
  • Low extractables
  • Designed for autoclaving or SIP under wet or dry conditions
  • 2D Matrix Marking for electronic traceability via barcode scanner

Quality Standards

  • All individual filter elements are integrity tested – test correlated to microbial retention
  • 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
  • Certificate of Test provided includes
    • Fabrication Integrity 
    • Bacterial Retention
    • Materials of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens

Products in this datasheet may be covered by one or more patents including :
EP 0 667 800
EP 0 982 061
EP 1 380 331
US 5,543,047
US 5,690,765
US 5,725,784
US 6,113,784
US 7,083,564
US 7,318,800

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Description

Fluorodyne EX grade EDF filters are 0.2 micron rated high capacity, low protein binding sterilizing grade filters. Incorporating a built-in prefiltration layer and validated to retain B. diminuta at a challenge level of 107 cfu/ cm2 of membrane, Fluorodyne EX grade EDF filters are ideal for the sterile filtration of cell harvest material and challenging intermediate and final bulk biological process fluids.

Pall's 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), supplied with -226 O-ring (Pall code 2 or code 7) fittings as standard.

AB-style filters with Fluorodyne EX grade EDF membrane feature a laid over pleat membrane construction and high effective filtration area (>1 m2 per 10” assembly) for outstanding throughput performance.

A validation package for Fluorodyne EX grade EDF filters supports the assurance of safety within your process.

Key Features and Benefits

  • Laid-over pleat filter construction allows for high flow rates and smaller filtration systems
  • Narrow core design for more area
  • Asymmetric built-in prefilter layer for higher dirt-holding capacity
  • Low protein and preservative binding
  • Low extractables
  • Designed for autoclaving or SIP under wet or dry conditions
  • 2D Matrix Marking for electronic traceability via barcode scanner

Quality Standards

  • All individual filter elements are integrity tested – test correlated to microbial retention
  • 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
  • Certificate of Test provided includes
    • Fabrication Integrity 
    • Bacterial Retention
    • Materials of Construction
    • Effluent quality for cleanliness, TOC and water conductivity, pH and pyrogens

Products in this datasheet may be covered by one or more patents including :
EP 0 667 800
EP 0 982 061
EP 1 380 331
US 5,543,047
US 5,690,765
US 5,725,784
US 6,113,784
US 7,083,564
US 7,318,800

Specifications

Materials Of Construction

 
Filter Membrane Prefilter Layer: Hydrophilic asymmetric PES
Final Filter Layer: Hydrophilic 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 Differential Pressure (Forward Direction) 5.5 bar (80 psi) at 40 °C
4.0 bar (58 psi) at 80 °C
Maximum Differential Pressure (Reverse Direction) 2.0 bar (30 psi) at 40 °C
 
2 In compatible fluids which do not soften, swell or adversely affect the filter or its materials of construction

Sterilization

 
Autoclave 5 x 60 minutes at 135°C
In Situ Steam³ 5 x 60 minutes at 135°C
 
3 Maximum differential pressure 1 bar in forward direction

Typical Extractables in Water at 20 °C*

 
< 50 mg after 4 hours extraction (per 10 in. cartridge)
 
* Tested on elements without pre-flushing

Nominal Effective Filter Area (EFA)

 
1.1 m² per 254 mm cartridge (11.8 ft² per 10 in. cartridge)
0.53 m² per 125 mm cartridge (5.7 ft² per 5 in. cartridge)
 


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

 
Values for 10 in. cartridge at 20°C  
Max. allowable Forward Flow (air test gas) Water wet 30 mL/min at 2760 mbar (40 psi)
 
** Contact Pall for multi-element integrity test values and recommended test procedures

Flow Rates

 
 

Type

Filter Cartridges

Use

Sterilizing-Grade Liquid Filtration

Ordering Information

 
Item Part Number
Fluorodyne® EX Grade EDF Membrane Filter Cartridge
Nominal Length 127 mm (5 in.); Pall Code 2 double O-ring (silicone elastomer), bayonet lock and flat top end cap*		 AB05UEDF2PH4
Fluorodyne® EX Grade EDF Membrane Filter Cartridge
Nominal Length 254 mm (10 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin*		 AB1UEDF7PH4
Fluorodyne® EX Grade EDF Membrane Filter Cartridge
Nominal Length 508 mm (20 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin*		 AB2UEDF7PH4
Fluorodyne® EX Grade EDF Membrane Filter Cartridge
Nominal Length 762 mm (30 in.); Pall Code 7 double O-ring (silicone elastomer), bayonet lock and fin*		 AB3UEDF7PH4
 
* Other adapter fittings and O-ring materials available on request

Product Summary

Fluorodyne® EX EDF Membrane Filter Cartridges retain microbial with their unique asymmetry and EX grade EDF filters. The AB-style cartridges are replicable and suitable for medium to large scale production. The filter has prefiltration built-in to hold more dirt and guarantee more efficient purification. The unit can be repeatedly autoclaved and SIP in either wet or dry conditions.

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