Life Science Filter

Protecting Life with Biosecurity Filtration

Sterilizing Filters PURIAGIS SP

  •  

    The PURIAGIS SP series filters are made of naturally hydrophobic polytetrafluoroethylene membrane (PTFE). They offer broad chemical compatibility for organic solvents sterilizing filtration.

     

     

    Advanced Bio-Pharma Filtration Solutions

    Enhance yield and ensure compliance with Feature-Tec’s precision-engineered filtration technologies.

    • Targeted Applications: mAb Production, Vaccine Processing, ADC Manufacturing, & Fermentation.

    • Core Technologies: Depth Filtration, Bioburden Reduction, & Automatic Integrity Testing.

    • Expert Services: Full Process Validation & Technical Support.

    • Global Compliance Guaranteed: Certified to GMP, USP, ICH, ISO 17025, EMA Annex 1, and PIC/S standards.

    Optimize your process today: marketing@feature-tec.com

     

    Product Feature

    • Excellent hydrophobicity

    • Resistant to high temperatures, high pressure

    • Withstand multiple sterilization cycles

    • Reliable retention of bacteria and particles

     

    Applications

    • Decontamination and filtration of organic solvents
    • Carification and decarburization filtration of organic solvents

     

    Dimensions

    Category Sub-category Capsule Filters (S / 2.5" / 5" / 10") Cartridge Filters (2.5" / 5" / 10" / 20" / 30")
    Nominal size (inches) - S, 2.5, 5, 10 2.5, 5, 10, 20, 30
    Filtration Area (m²) φ63 S: 180cm²; 2.5": 0.073; 5": 0.23; 10": 0.63 2.5": 0.12; 5": 0.25; 10": 0.50; 20": 1.0; 30": 1.50
      φ70 - 2.5": 0.17; 5": 0.35; 10": 0.70; 20": 1.40; 30": 2.10
    Pore Size - 0.22μm 0.22μm
    Materials of Construction - Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PTFE Support Layer: PPEnd Cap: PPAdaptor: PPSealing Ring: Silicon / Fluoroelastomer / EPDM / FEP+FKMHot-Melt Technology: Adhesive free technologyMembrane material: PTFE
    Maximum differential pressure Forward (L, M) 5bar (72.5psi) @20°C3bar (43.5psi) @50°C 5bar (72.5psi) @20°C2bar (29psi) @80°C
      Forward (S) 4bar (58psi) @20°C -
      Backward 2bar (29psi) @20°C1.5bar (22psi) @50°C 2bar (29psi) @20°C
    Sterilization - Autoclave: 134°C30min25 times 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)
    Component Material Toxicity - Components materials meet the criteria of the USP<88> Biological Reactivity for Class VI Components materials meet the criteria of the USP<88> Biological Reactivity for Class VI
    Cleanness - Comply with FDA 21 CFR 211.72 and 210.3(b)(5)(6) for fiberless shedding filters, and USP<788> for insoluble particulate levels in the rinse solution. Comply with FDA 21 CFR 211.72 and 210.3(b)(5)(6) for fiberless shedding filters, and USP<788> for insoluble particulate levels in the rinse solution.
    Ingredient Material Toxicity - Component materials meet USP <88> Class VI plastics reaction test standards. Component materials meet USP <88> Class VI plastics reaction test standards.
    Bacterial Endotoxin - Aqueous extraction contains <0.25 EU/mL which meet USP<85> requirements Aqueous extraction contains <0.25 EU/mL which meet USP<85> requirements
    Integrity - Each cartridge/filter passes 100% integrity testing before it leaves the factory. Each cartridge/filter passes 100% integrity testing before it leaves the factory.
    Production environment - All produced in 100,000 class clean room All produced in 100,000 class clean room
Sterilizing Filters PURIAGIS SP
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  • Sterilizing Filters PURIAGIS 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 180cm2 0.073 0.23 0.63 D63
    D70
    0.25
    0.35
    0.50
    0.70
    1.0
    1.40
    1.50
    2.10

    15cm ²

    180cm2

    0.073

    0.23

    0.63

    D63
    D70

    0.25
    0.35
    0.50
    0.70
    1.0
    1.40

    1.50
    2.10

    double layer
    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
    Sealing ring: silicone rubber/EPDM/fluorine rubber/fluorine rubber
    hot-melt technology adhesive-free hot-melt sealing
    Membrane material: hydrophobic polytetrafluoroethylene (PTFE)

     

    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 ℃

    Sterilization method

    Withstand high pressure steam sterilization

    High pressure steam sterilization: 134 ℃ * 30min * 25 times

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

    bacterial interception

    >107Cfu/cm♭ B.diminuta (ATCC 19146)

    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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