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Super-Dura Filter Cartridges
Hydrophililc PTFE Membrane · Sterilizing-grade Filter LHPF Series

Super-Dura Filter Cartridges are designed for the majority of pharmaceutical liquids, but especially for solvent-containing liquids and ophthalmic solutions. These filters are composed of a hydrophilic PTFE membrane which provides great chemical and heat tolerance.



Features and Benefits

  • Hydrophilic PTFE membrane which requires no pre-wetting
  • Great chemical compatibility especially for solvent-containing liquids
  • Minimal preservative binding in ophthalmic solutions
  • Clean membrane with very low gravimetric extractable


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

  • Antibiotics

  • LVP & SVP

  • Ophthalmic Solutions

  • Disinfectants and Sanitizing Agents

  • Large Batch Solutions

  • Solvent-containing Liquid

  • Specification
  • Performance
  • Biological Satety
  • Ordering Information

Materials of Construction


Filter Media

SLHPF Single-Layer Hydrophilic PTFE Membrane

DLHPF Double-Layer Hydrophilic PTFE Membrane

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 Area0.65m² / Φ 69-10 inch




Sterilization


Inline Steam Sterilization

up to 10 cycles (135°C for 30min< 0.3 bar per cycle), SLHPF

up to 35 cycles (135°C for 30min< 0.3 bar per cycle), DLHPF

Autoclaveup to 120 cycles (130°C for 30min per cycle)

 


Integrity Test Data


Bubble Point

BP: ≥ 0.32 MPa(water), DLHPF(0.22 μm)

Diffusion FlowDF: ≤ 30 ml/min/10”@ 0.22 MPa, DLHPF(0.22 μm)

 





 



Ordering Infomation
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