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CHC Sterilizing-Grade PES Capsule 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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    • 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—Alicap® L-type Capsule Filter

    Product Specifications

     

    Alicap® L300

    Alicap® L600

    Alicap® L02

    Alicap® L04

    Alicap® L5

    Alicap® L10

    Alicap® L20

    Body Diameter
    Maximum Width
    Maximum Length

    67 mm
    77 mm
    100.5 mm

    67 mm
    77 mm
    122 mm

    72 mm
    96 mm
    164 mm

    72 mm
    96 mm
    217 mm

    107 mm
    147 mm
    224 mm

    107 mm
    147 mm
    362 mm

    92 mm

    132 mm

    575 mm

    Materials of

    Construction

    Membrane

    Hydrophilic polyethersulfone (PES)

    Supporting Layer

    Polypropylene (PP)

    O-rings

    Silicone

    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 )

    -

    ≤2.5 mL/min

    ≤5.5 mL/min

    ≤9.5 mL/min

    ≤12.5 mL/min

    ≤25 mL/min

    ≤50 mL/min

    Working characteristics

    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

    Resistance

    Autoclave(A&G): 131℃, 30 min, 3 cycles

    Gamma-compatible (G): 25-45 kGy

    *Capsule filters can't be sterilized by SIP,

    sterile type capsule filters can't be sterilized again

    Autoclave(A&G): 131℃, 30 min, 5 cycles

    Gamma-compatible (G): 25-45 kGy

    *Capsule filters can't be sterilized by SIP,

    sterile type capsule filters can't be sterilized again

    Filtration Area

    230 cm2

    430 cm2

    0.11 m2

    0.19 m2

    0.3 m2

    0.6 m2

    1.2 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 Alicap L-type Capsule Filter

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