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PES 0.2μm Cartridge Filters

Alioth Alipore® DHF Single-layer Cartridge Filter is a 0.2μm single-layer polyethersulfone (PES) filter that can efficiently retain bacteria (LRV > 6) and particulate contaminants. It has wide chemical compatibility and low leaching level, thus suitable for the bioburden control and pre-filtration of various fluids. It can provide more effective protection at different stages of bioprocess, prolonging the service life of sterilizing filters and safeguarding other processing systems.

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    • High flow rate, high capacity.

    • Verified bioburden control capability.

    • Withstand multiple cycles of sterilization.

    • Wide chemical compatibility.

     

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    • Bioburden control

    • Filtration of terminally sterilized products

    • Filtration of clarified cell culture fluid

    • Pre-filtration for column protection

    • Intermediate product filtration

    • Pre-filtration before terminal sterilization, etc.

     

  • Product Specifications

      10 inch 20 inch 30 inch

    Dimensions

    Diameter
    Maximum Length

     

    69 mm
    320 mm

     

    69 mm
    560 mm

     

    69 mm
    800 mm
    Filtration Area 0.66 m2 1.32 m2 1.98 m2
    Pore size 0.2 μm
    Materials of Construction

    Filter membrane: Hydrophilic polyethersulfone (PES)       

    Supporting Layer: Polypropylene (PP)
    O-rings of capsules vent: Silicone

    Liner/Cartridge body: Polypropylene (PP)
    End caps: Polypropylene/ Polycarbonate (PP/PC)
    Bacterial Retention > 106 / 10inch B. diminuta ( ATCC® 19146™ )
    Maximum Differential Pressure Forward: 5 bar ( 72.5 psi ) @ 25℃ / 1.5 bar ( 21.75 psi ) @ 80℃ / Reverse: 2 bar ( 29 psi ) @ 25℃
    Bubble Point ≥3180 mbar（51 psi）(wetted with H₂O, 20℃, compressed air）
    Sterilization Parameters 135℃, 30 minutes, 20 cycles of high-pressure sterilization or 10 cycles of sterilization in place
    Biological Safety All the construction components of this cartridge comply with the requirements for biological safety of Class Vl plastics in current USP < 88 >
    Indirect Food Additive The primary construction components of this cartridge comply with the reguirements for food contact materials as stipulated in EU 1935 / 2004 / EC and FDA 21 CFR 177-182
    Cleanliness Cleanliness meets the requirements for nonfiber releasing filter as specified in FDA 21 CFR 211.72 and 210.3 (b) (5) (6), and the level of insoluble particles in rinsing liquid meets the requirements of USP < 788 >
    Endotoxin The endotoxin level of cartridge rinsing liquid is < 0.25 EU/mL as indicated by gel method, which complies with the requirements of USP < 85 >
    Integrity Each filter has passed the integrity test
    TOC / Conductivity TOC < 0.5 mg/L, Conductivity < 1.3 μS/cm
    Manufacturing Environment Manufactured in conformance with cGMP

     

    Test Results of Flow Differential Pressure