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PES 0.45+0.2 μm Sterilizing-Grade Cartridge Filters

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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    • Highly asymmetric Double-layer PES membrane.

    • High flux and increased capacity.

    • Validated reliable bacterial retention.

    • Wide chemical compatibility (pH 1-14).

    • 100% integrity tested.

     

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    • Buffers

    • Final Fill

    • Cell Culture Media

    • Process Intermediates

    • Water for pharmaceutical process

     

  • Product Specifications —Cartridge Filter

      Cartridge Filter
    (5 inch)
    Cartridge Filter
    (10 inch)
    Cartridge Filter
    (20 inch)
    Cartridge Filter
    (30 inch)
    Dimensions
    Diameter
    Maximum Length

     

    69 mm
    150 mm

     

    69 mm
    320 mm

     

    69 mm
    560 mm

     

    69 mm
    800 mm

    Filtration Area 0.3 m2 0.6 m2 1.2 m2 1.8 m2
    Pore Size 0.45+0.2 μm
    Materials of
    Construction
    Filter membrane: Hydrophilic polyethersulfone (PES)
    Supporting Layer: Polypropylene
    O-rings of cartridges: Silicone
    Liner / cartridge body: Polypropylene
    End caps: Polypropylene / Polycarbonate
    Bacterial Retention >107 cfu /cm2 B. diminuta ( ATCC® 19146TM )
    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℃
    Bubble Point ≥3520 mbar(51 psi)(wetted with H2O, 20℃, compressed air)
    Diffusion Through a water wet membrane at 2760 mbar (40 psi) (20℃, compressed air )
    ≤12.5 mL/min ≤25 mL/min ≤50 mL/min ≤75 mL/min
    Sterilization Steam in place: 136℃, 30 min, 30 cycles
    Autoclave: 131℃, 30 min, 30 cycles
    Biological Safety All the construction components of this filter comply with the requirements for biological safety of Class VI plastics in current USP <88>
    Indirect Food Additive The primary construction components of this filter comply with the requirements 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 CFR211.72 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 Filtrate of this filter , TOC<0.5 mg/L, Conductivity<1.3 μS/cm
    Integrity Filters are 100% integrity tested
    Manufacturing
    Environment
    Manufactured in conformance with cGMP

     

    Typical Flow Characteristics

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

     

    Water Flow Rate and Pressure Drop-Alioth Alipore® CHC 0.45+0.2μm Alicap L-type Capsule Filter

    KFBEC52M3**S1*)

     

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