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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.

     

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    • Pre-fltration for buffers

    • Cell culture media

    • Pre-filtration for column protection

    • Pre-filtration before terminal sterilization, etc

     

  • Product Specifications

      5 inch 10 inch 20 inch 30 inch

    Dimensions

    Diameter
    Maximum Length

     

    69 mm
    150 mm

     

    69 mm
    320 mm

     

    69 mm
    560 mm

     

    69 mm
    800 mm
    Filtration Area 0.32 m2 0.65 m2 1.3 m2 1.95 m2
    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)
    Pore Size 0.45 μm
    Maximum Differential
    Pressure    		 Forward: 5.0 bar ( 72.5 psi ) @ 25℃ / 3.0 bar ( 43.5 psi ) @ 80℃ / Reverse: 2.0 bar ( 29.0 psi ) @ 25℃
    Sterilization Parameters 135℃, 30 minutes, 10 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 >
    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