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PES 0.45μm Cartridge Filters

Alioth Alipore® CHF PES prefilters can provide effective bioburden control and particle contaminants removal with good chemical compatibility and low level extractable. Alipore® CHF filters aresuitable for bioburden control and prefiltration application of various kind of fluid,provide effective protection to downstream sterilizing-grade filter and other processsystem in different steps of bioprocess. Meet the common needs of the pharmaceutical industry for liquid pre-filtration.

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    • High flow rate, high capacity.

    • Valicated bioburden reduction.

    • Stable performance, Withstand multiple.

    • Cycles of sterilization.

    • Broad chemical compatibility.

     

  •  

    • Pre-fltration for buffers

    • Cell culture media

    • Pre-filtration for column protection

    • 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)

    Working characteristics

    Maximum Differential

    Pressure

    Forward: 5.0 bar（72.5 psi）@ 25°C/3.0 bar（43.5 psi）@ 80°C

    Reverse: 2.0 bar（29.0 psi）@ 25°C

    Sterilization

    Resistance

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

    Autoclave: 135℃, 30 min, 10 cycles

    Filtration Area

    0.32 m2

    0.65 m2

    1.3 m2

    1.95 m2

    Pore Size

    0.45 μm

    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

    TOC﹤0.5 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