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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

    Product Specifications

     

    5 inch

    10 inch

    20 inch

    30 inch

    Diameter
    Maximum Length

    69 mm
    150 mm

    69 mm
    320 mm

    69 mm
    560 mm

    69 mm
    800 mm

    Materials of

    Construction

    Membrane

    Hydrophilic polyethersulfone (PES)

    Supporting Layer

    Polypropylene (PP)

    O-rings

    Silicone、Ethylene propylene diene monomer(EPDM)

    Core/Cage/End caps/Housing

    Polypropylene (PP)

    Integrity testing

    Bubble Point

    ≥3180 mbar(46 psi)(wetted with H2O, 20℃, compressed air)

    Working characteristics

    Maximum Differential

    Pressure

    Forward: 5.0 bar(72.5 psi)@ 25℃/1.5 bar(21.75 psi)@ 80℃

    Reverse: 2.0 bar(29 psi)@ 25℃

    Sterilization

    Resistance

    In-line steam: 135℃, 30 min,10 cycles

    Autoclave: 135℃, 30 min, 20 cycles

    Filtration Area

    0.32 m2

    0.66 m2

    1.32 m2

    1.98 m2

    Pore Size

    0.2 μm

    Bacterial Retention

    TR﹥106 B. diminuta ( ATCC® 19146TM )

    Biological Safety

    All construction components meet the biological safety requirements refering to USP<88> Class VI plastic and USP<87>

    Indirect Food Additive

    All component materials meet the requirements of Indirect Food Additive cited in EU 1935/2004/EC and FDA 21 CFR 177-182

    Cleanliness

    Meets the requirements for a ‘non-fiber releasing’ filter defined in FDA 21 CFR 211.72 and 210.3 (b) (5) (6), and particulate matter meets the requirements of USP<788>

    Endotoxin

    Endotoxin﹤0.25 EU/mL by LAL test method, which complies with the requirements of USP<85>

    TOC/Conductivity

    TOC0.5 mg/L, Conductivity﹤1.3 μS/cm

    Manufacturing Integrity

    100% integrity test passed

    Manufacturing Environment

    Manufactured in conformance with cGMP

     

    Test Results of Flow Differential Pressure