Life Science Filter

Protecting Life with Biosecurity Filtration

Sterilizing Filters LOPAC INNOVEX SP

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    LOPAC INNOVEX SP series filters are made of modified polyethersulfone membrane (PES) with good hydrophilicity and low protein adsorption. They are suitable for sterilizing filtration of process fluid, buffer and column protection.

     

    Product Feature

    • Reliable bacterial retention

    • Excellent chemical compatibility (pH 1-14)

    • Unique double layer membrane design for increased loading capacity

    • Rugged construction for multiple sterilization cycles

     

    Applications

    • Sterilization filtration of cell culture media
    • Buffer filtration
    • Pre-Column / Pre-Ultrafiltration Protective Filtration
    • Sterilization Filtration of end products

     

    Dimensions

    Parameter Disc Filters Capsule Filters Cartridge Filters
    Nominal Size (inches) / S / 2.5" / 5" / 10" 2.5" / 5" / 10" / 20" / 30" (φ63 / φ70)
    Filtration Area (Single Layer) 3.5cm² / 20cm² S: 180cm²2.5": 0.073m²5": 0.23m²10": 0.63m² φ63: 2.5":0.11m² / 5":0.23m² / 10":0.45m² / 20":0.90m² / 30":1.35m²φ70: 2.5":0.15m² / 5":0.30m² / 10":0.60m² / 20":1.20m² / 30":1.80m²
    Filtration Area (Double Layer) 3.5cm² / 20cm² S: 160cm²2.5": 0.065m²5": 0.20m²10": 0.60m² φ63: 2.5":0.11m² / 5":0.23m² / 10":0.45m² / 20":0.90m² / 30":1.35m²φ70: 2.5":0.15m² / 5":0.30m² / 10":0.60m² / 20":1.20m² / 30":1.80m²
    Pore Size 0.22μm, 0.45μm+0.22μm 0.22μm, 0.45μm+0.22μm 0.22μm, 0.45μm+0.22μm
    Materials of Construction Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PES Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PES Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PES
    Max Forward Differential Pressure 5bar (72.5psi) @20°C L/M: 5bar (72.5psi) @20°C / 3bar (43.5psi) @50°CS: 4bar (58psi) @20°C 5bar (72.5psi) @20°C / 2bar (29psi) @80°C
    Max Reverse Differential Pressure 2bar (29psi) @20°C 2bar (29psi) @20°C / 1.5bar (22psi) @50°C 2bar (29psi) @20°C
    Sterilization Resistant to autoclaving and irradiation Autoclave: 134°C30min25 timesElectron beam irradiation: <50 kGy Autoclave: 134°C30min25 timesOnline steam sterilization: 134°C30min25 times (Δp≤0.3bar)
    Bacterial Interception >10⁷cfu / cm² B.diminuta (ATCC 19146) >10⁷cfu / cm² B.diminuta (ATCC 19146) >10⁷cfu / cm² B.diminuta (ATCC 19146)
    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 (meets USP<85> requirements) Aqueous extraction <0.25 EU/mL (meets USP<85> requirements) Aqueous extraction <0.25 EU/mL (meets USP<85> requirements)
    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
Sterilizing Filters LOPAC INNOVEX SP
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  • Sterilizing Filters LOPAC INNOVEX SP

Product Parameters

  • Filter Type

    dish filter

    capsule filter

    Cartridge filter

    Nominal Size (inches)

    φ50mm

    S

    2.5

    5

    10

    Specifications

    5

    10

    20

    30

    Filtration area
    (M²)

    single layer

    15cm ²

    180cm ²

    0.073

    0.23

    0.63

    D63
    D70

    0.23
    0.3

    0.45
    0.6

    0.9
    1.2

    1.35
    1.8

    double layer

    15cm ²

    160cm ²

    0.065

    0.2

    0.6

    D63
    D70

    0.23
    0.3

    0.45
    0.6

    0.9
    1.2

    1.35
    1.8

    filter pore size

    0.22μm

     

    Structure material

    Support layer: Polypropylene (PP)
    Housing/End caps/Fins: Polypropylene (PP)
    Interface: Polypropylene (PP),222/226 with built-in stainless steel reinforcement option
    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℃

    Reverse

    2bar(29psi)@ 20 ℃

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

    2bar(29psi)@ 25°C

    Sterilization method

    Withstand high pressure steam sterilization
    and radiation-resistant sterilization

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

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

    bacterial interception

    > 10cfu/cm2. B.diminuta (ATCC19146)

    biological safety

    The structural components of this filter element meet the current USP<88> grade VI material 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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