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Duredunty Filter Cartridges
Double-layer PES Membrane · Sterilizing Grade

Duredunty  Filter Cartridges use a double-layer PES membrane which provides great reliability in filtration and sterilization. They are designed for the filtration of a broad range of pharmaceutical products and the removal of particles, cysts, oocysts and bacteria in aqueous filtration filtration application, while providing superior low rates and high particle removal efficiency when compared to other sterilizing grade filter cartridges.

Features and Benefits

  • Double-layer hydrophilic PES membrane which requires no pre-wetting
  • Asymmetric pre-filter layer provides longer service life and lower filtration cost
  • Broad chemical compatibility (pH 1-14)
  • Provides 10x the safety when compared to normal PES filters
  • Design allows for multiple autoclave cycles (up to 30) and extended use


Quality Standards:

  • Bacterial quantitative retention of 107 CFU/cm2 Brevundimonas Diminuta (ATCC 19146) according to ASTM F838 methodology .
  • 100% Integrity testing in manufacturing .
  • Each filter is fully traceable with unique serial number.

  • Manufactured in a facility which adheres to ISO 9001: 2015 Practices .
    • Bacterial Endotoxin : Aqueous extraction of autocalved filter contains <0.25 EU/ml as determined by Limulus Amebcyte Lysate (LAL),USP<85>.

    • Non-fiber Releasing : Component materials meet the criteria for a "Non-fiber-releasing filter" as defined in 21 CFR 210.3(b)(6).

    • Component Material Toxicity :Meet the requirement of USP <87> In Vitro Cytotoxicity Test ; Meet the Criteria of USP<88> Biological Reactivity Test for Class VI-121℃ plastics

    • TOC/Conductivity at 25 ℃：Autoclaved filter effluent meet the USP<643> for Total Organic Carbon and USP<645> for

    • Water Conductivity per WFI requirements after a UPW flush of specified volume .

    • Particle Shedding : Autoclaved filter effluent meet the USP<788>for large volume Injections .

    • Indirect Food Additive：All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182 , and EU framework regulation [1935/2004/EC].




Typical Applications

  • Biological Vaccines

  • Blood Products

  • LVP and SVP

  • Lyophilization Freeze-dried Powder

  • Ophthalmic Solutions

  • Sterile API


  • Specification
  • Performance
  • Biological Satety
  • Ordering Information

Materials of Construction


Filter Media

Double-Layer PES Membrane
(Asymmetric PES + Symmetric PES)

Support

Polypropylene

Core/Cage/End Caps

Polypropylene




Operating Conditions


Max. Operating Pressure

6.9 bar (100 psi) at 25 °C

4.0 bar (58 psi) at 60 °C

2.4 bar (35 psi) at 80 °C

Max. Differential Pressure

Forward

6.9 bar (100 psi) at 25 °C

4.0 bar (58 psi) at 60 °C

2.4 bar (35 psi) at 80 °C

Reverse

3.0 bar (44 psi) at 25 °C

1.0 bar (15 psi) at 80 °C

Effective Filtration Area0.6m² / Φ 69-10 inch




Sterilization


Inline Steam Sterilization

up to 100 cycles (135°C for 30min< 0.3 bar per cycle)

Autoclaveup to 200 cycles (130°C for 30min per cycle)

 


Integrity Test Data


Bubble Point

≥ 0.34 MPa(water), 0.45+0.22μm

Diffusion Flow≤ 25 ml/min/10”@ 0.275MPa (water), 0.45+0.22μm

 





 



Food and Biological Safety

Extractables< 30mg per 10 inch
Endotoxins< 0.25EU/mL

Meets the requirements for food contact:  European Regulation (EC) Number 1935/2004


Integrity Test Parameters


2210
=0.22+0.1μm		2222
=0.22+0.22μm		4522
=0.45+0.22μm		4545
=0.45+0.45μm		6545
＝0.65+0.45μm
Diffusional Flow
(10″Cartridge)		  ≤25ml/min 
 @3000mbar		  ≤15ml/min 
  @2750mbar		  ≤25ml/min 
  @2750mbar		  ≤15ml/min 
  @1600mbar

  ≤25ml/min 
  @1600mbar

Bubble Point
(in water@ 23°C)		   ≥ 3.8 bar   ≥ 3.4 bar   ≥ 3.4 bar   ≥ 2.0 bar   ≥ 2.0 bar

The Integrity Test is a non-destructive test that can be performed by the user to ensure the filter is installed correctly and ready for operation.





Ordering Infomation


TypeRemoval RatingsEnd CapNominal LengthSeal MaterialIndustry

DPSDDT






2210=0.22+1.0μm

2222=0.22+0.22μm

4522=0.45+0.22μm
4545=0.45+0.45μm

6522=0.65+0.45μm



HSF=226 /Fin (PBT Insert)

HSC=226 /Flat (PBT Insert)

HTF=222 /Fin (PBT Insert)

HTC=222 /Flat (PBT Insert)

DOE=Double Open End


05= 5"

10=10"

20=20"

30=30"

40=40"


S=Silicone

E=EPDM

V=Viton

P=PFA/Viton


P=Pharmaceutical






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