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China Suppliers Factory Challenge Pore® PES Low Protein-Binding Hydrophilic Filters for Biopharmaceutical Processes

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The Challenge IM Capsule Filters are expertly designed to address essential filtration needs across five key series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration. With particle retention capabilities ranging from 0.1 to 30 μm, these filters are ideal for comprehensive biopharmaceutical applications, from cell culture clarification to final product sterilization. Our filters are engineered to support high-temperature steam sterilization and gamma irradiation, making them compatible with a variety of biopharmaceutical solvents commonly used in China and beyond.

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All molded parts and sealing components are free of colorants and conform to Class VI and ISO 10993 biocompatibility standards, minimizing leachables and extractables while ensuring hygienic processing. Each filter undergoes rigorous dual integrity testing during production, utilizing two independent test methods to guarantee a 100% pass rate straight from the factory.

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These filters meet ISO 9001 quality management and GMP standards, and successfully pass essential tests such as USP endotoxin, USP / biocompatibility, and USP extractables, ensuring no animal-derived TSE/BSE risks. All products are validated by reputable international agencies like SGS and NF, providing reliable filtration solutions for the entire biopharmaceutical process. Choose our filters for superior quality from trusted suppliers in the industry.

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    Features

    • Unique dual-layer design
    • Reliable bacteria and particle retention
    • Broad chemical compatibility (pH 1-14)
    • Extremely low extractables
    • Low protein binding

    Typical Applications

    • Prefiltration of cell culture media
    • Buffer filtration
    • Pre-column / Pre-ultrafiltration protective filtration

    Operating Conditions

    Maximum Operating Temperature
    80℃
    Maximum Differential Pressure
    0.55MPa / 25℃
    0.1MPa / 80℃

    Biosafety

    Endotoxin < 0.25 EU/mL
    Biocompatibility
    • Compliant with USP <87> Non-cytotoxic
    • Meets USP <88> Class VI plastic biocompatibility requirements

    Filter Dimensions

    Size 01
    0.05 ㎡
    Size 05
    0.28 ㎡
    Size 10
    0.55 ㎡

    Sterilization

    • Challenge Pore® PES capsule filter is capable of being sterilized by high-temperature steam (121 °C for 30 minutes, up to 5 cycles) or by gamma irradiation (25–40 kGy).

    Material Construction

    Component Material / Specification
    Filter Membrane Hydrophilic Polyethersulfone (PES)
    Inner Cage, Outer Cage Polypropylene (PP)
    Capsule Housing Polypropylene (PP)
    Capsule Vent O-Ring Silicone Rubber
    Filtration Accuracy 0.8+0.45μm / 1.0+0.65μm / 1.0+0.8μm

    Frequently Asked Questions (FAQ)

    What are the primary applications for the Challenge Pore® PES capsule filters?
    They are typically used for the prefiltration of cell culture media, buffer filtration, and protective pre-column or pre-ultrafiltration filtration tasks.
    What sterilization methods can be applied to these filters?
    The filters can be sterilized using high-temperature steam at 121 °C for 30 minutes (up to 5 cycles) or through gamma irradiation within a range of 25–40 kGy.
    What are the key biosafety standards met by these filters?
    They exhibit endotoxin levels of less than 0.25 EU/mL, comply with USP <87> for non-cytotoxicity, and meet USP <88> Class VI plastic biocompatibility requirements.
    What materials are used in the construction of the capsule filter?
    The filter membrane is made of Hydrophilic Polyethersulfone (PES), the inner/outer cages and capsule housing are made of Polypropylene (PP), and the vent O-ring is constructed from Silicone Rubber.
    What are the maximum operating pressure limits?
    The maximum differential pressure is 0.55 MPa at a temperature of 25℃ and decreases to 0.1 MPa at an elevated temperature of 80℃.