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CHC Sterilizing-Grade PES Cartridge Filter

Product Introduction
Alioth Alipore® CHC double-layer polyethersulfone (PES) filters are suitable for a variety of sterile filtration of process fluids with both cartridge and disposable capsule format available. The filter has passed strict sterilization performance validation. It features a built-in pre-filtration layer to achieve high flow rate and capacity, and thereby optimize your process efficiency and cost effectiveness.

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Depth Stacked DataSheet
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    • Highly asymmetric Double-layer PES membrane.

    • High flux and increased capacity.

    • Validated reliable bacterial retention.

    • Wide chemical compatibility (pH 1-14).

    • 100% integrity tested.

     

  •  

    • Buffers

    • Final Fill

    • Cell Culture Media

    • Process Intermediates

    • Water for pharmaceutical process

     

  • Product Specifications —Cartridge Filter

    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

    ≥3520 mbar(51 psi)(wetted with H2O, 20℃, compressed air)

    Diffusion Flow

    Test pressure 2760 mbar (40 psi)(20℃, compressed air)

    ≤12.5 mL/min

    ≤25 mL/min

    ≤50 mL/min

    ≤75 mL/min

    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: 136℃, 30 min, 30 cycles

    Autoclave: 131℃, 30 min, 30 cycles

    Filtration Area

    0.3 m2

    0.6 m2

    1.2 m2

    1.8 m2

    Pore Size

    0.45+0.2 μm

    Bacterial Retention

    >107 cfu/cm2 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

    TOC﹤0.5 mg/L, Conductivity﹤1.3 μS/cm

    Manufacturing Integrity

    100% integrity test passed

    Manufacturing Environment

    Manufactured in conformance with cGMP

     

    Typical Flow Characteristics

    Water Flow Rate and Pressure Drop -Alipore® CHC 0.45+0.2μm Cartridge Filters

     

     

     

    *T1, T3, B5, B7 represent different interface types, see order information for details.