Life Science Filter

Protecting Life with Biosecurity Filtration

Bioburden Control Filters LOPAC INNOVEX PF

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    LOPAC INNOVEX PF Filters are made of hydrophilic polyethersulfone membrane (PES) with good hydrophilicity and low protein adsorption. They are suitable for the bacteria-reducing filtration of bioprocess fluids with easy adsorption and complex ingredient. They can reduce the microbial contamination level and meet the process requirements.

     

    Product Feature

    • Unique double layer design

    • Reliable bacterial and particulate retention

    • Excellent chemical compatibility (pH: 1-14)

    • Less dissolution

    • Low protein adsorption

     

    Applications

    • Decontamination of cell culture media
    • Filtration of buffers
    • Pre-column / Pre-ultrafiltration protection

     

    Dimensions

    Parameter Disc Filters Capsule Filters Cartridge Filters
    Nominal Size (in) / S / 2.5" / 5" / 10" 2.5" / 5" / 10" / 20" / 30" (φ63/φ70)
    Filtration Area (Single Layer) 3.5cm² / 20cm² S: 180cm²; 2.5": 0.073m²; 5": 0.23m²; 10": 0.63m² φ63: 2.5":0.11/5":0.23/10":0.45/20":0.90/30":1.35m²φ70: 2.5":0.15/5":0.30/10":0.60/20":1.20/30":1.80m²
    Filtration Area (Double Layer) 3.5cm² / 20cm² S: 160cm²; 2.5": 0.065m²; 5": 0.20m²; 10": 0.60m² φ63: 2.5":0.11/5":0.23/10":0.45/20":0.90/30":1.35m²φ70: 2.5":0.15/5":0.30/10":0.60/20":1.20/30":1.80m²
    Pore Size 0.8μm+0.45μm、1.2μm+0.45μm、0.45μm、0.22μm、0.45+0.22μm、0.65+0.22μm、0.8+0.22μm 0.8μm+0.45μm、1.2μm+0.45μm、0.45μm、0.22μm、0.45+0.22μm、0.65+0.22μm、0.8+0.22μm 0.8μm+0.45μm、1.2μm+0.45μm、0.45μm、0.22μm、0.45+0.22μm、0.65+0.22μm、0.8+0.22μm
    Materials of Construction PP support/end cap/adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; PES membrane PP support/end cap/adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; PES membrane PP support/end cap/adaptor; Silicon/Fluoroelastomer/EPDM/FEP+FKM seal; Adhesive-free hot-melt; PES membrane
    Max Forward ΔP 5bar (72.5psi) @20°C L/M: 5bar@20°C / 3bar@50°CS: 4bar@20°C / 2bar@50°C 5bar@20°C / 2bar@80°C
    Max Reverse ΔP 2bar (29psi) @20°C 2bar@20°C / 1.5bar@50°C 2bar (29psi) @20°C
    Sterilization Resistant to autoclaving and irradiation Autoclave: 134°C30min25 times; Irradiation: <50 kGy Autoclave: 134°C30min25 timesOnline steam sterilization: 134°C30min25 times (Δp≤0.3bar)
    Component Material Toxicity Meets USP<88> Class VI Biological Reactivity criteria Meets USP<88> Class VI Biological Reactivity criteria Meets USP<88> Class VI Biological Reactivity criteria
    Cleanness Complies with FDA 21 CFR 211.72/210.3(b)(5)(6) & USP<788> Complies with FDA 21 CFR 211.72/210.3(b)(5)(6) & USP<788> Complies with FDA 21 CFR 211.72/210.3(b)(5)(6) & USP<788>
    Ingredient Material Toxicity Meets USP<88> Class VI plastics reaction test standards Meets USP<88> Class VI plastics reaction test standards Meets USP<88> Class VI plastics reaction test standards
    Bacterial Endotoxin Aqueous extraction <0.25 EU/mL (USP<85> compliant) Aqueous extraction <0.25 EU/mL (USP<85> compliant) Aqueous extraction <0.25 EU/mL (USP<85> compliant)
    Integrity 100% integrity tested before factory delivery 100% integrity tested before factory delivery 100% integrity tested before factory delivery
    Production Environment 100,000-class clean room 100,000-class clean room 100,000-class clean room
Bioburden Control Filters LOPAC INNOVEX PF
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  • Bioburden Control Filters LOPAC INNOVEX PF

Product Parameters

  • Filter Type

    dish filter

    capsule filter

    Cartridge filter

    Nominal size (inches

    φ50mm

    S

    2.5

    5

    10

    Specifications

    2.5

    5

    10

    20

    30

    Filtration area
    (M²)

    single layer

    15cm2

    180cm ²

    0.073

    0.23

    0.63

    D63
    D70

    0.11
    0.15

    0.23
    0.30

    0.45
    0.60

    0.90
    1.20

    1.35
    1.80

    double layer

    15cm2

    160cm ²

    0.065

    0.20

    0.60

    D63
    D70

    0.11
    0.15

    0.23
    0.30

    0.45
    0.60

    0.90
    1.20

    1.35
    1.80

    filter pore size

    0.65μm 0.22μm .22μm .22μm . 2μm 0.22μm·0.8μm·············································································································· 2μm 0.45μm

     

    Structure material

    Support layer: Polypropylene (PP)
    Housing/End caps/Fins: Polypropylene (PP)
    Interface: Polypropylene (PP),222/226 with built-in stainless steel reinforcement
    Sealing ring: silicone rubber/EPDM/fluorine rubber/fluorine rubber
    Hot melt technology: hot melt sealing without adhesive
    Membrane material: hydrophilic polyethersulfone (PES)

     

    Maximum operating differential pressure

    Forward

    2bar(29psi)@ 20 ℃

    L 、 M:5bar(72.5psi)@ 20℃
    3bar(43.5psi)@50℃

    5bar(72.5psi)@25℃
    2bar(29psi)@ 80 ℃

    S:4bar(58psi)@20℃
    2bar(29psi)@ 50 ℃

    Reverse

    2bar(29psi)@ 20 ℃

    2bar(29psi)@ 20 ℃
    1.5bar(22psi)@50℃

    2bar(29psi)@ 25 ℃

    Sterilization method

    Resistant to high pressure steam sterilization and irradiation sterilization

    High pressure steam sterilization: 134 ℃ * 30min * 25 times
    Irradiation sterilization:<50 kGy

    High pressure steam sterilization: 134 ℃ * 30min * 25 times
    Online steam sterilization: 134 ℃ * 30min * 25 times (△p≤ 0.3bar)

    biological safety

    The structural components of this filter element meet the current USP<88> Class VI plastic biosafety requirements

    Cleanliness

    Meet the requirements of FDA21CFR211.72 and 210.3 (B)(5)(6) for non-fiber shedding filters, and the level of insoluble particles in the flushing fluid meets the requirements of USP<788>

    Toxicity of ingredients and materials

    Comply with USP<88> Response Test for Class V Plastics

    endotoxin

    The endotoxin level of the filter element flushing fluid tested by gel method <0.25EU/mL meets the requirements of USP<85>

    integrity

    100% of each cartridge/filter passed the integrity test before leaving the factory

    Production Environment

    All in one hundred thousand clean workshop production

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