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China Suppliers: Challenge Pore® PES Low Protein-Binding Hydrophilic Filters from Reliable Factory

The Challenge IM Capsule Filters are engineered to address the critical needs of the biopharmaceutical industry in China, offering five essential 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 excel in applications from cell culture clarification to final product sterilization. Manufactured by top suppliers, the filters support high-temperature steam sterilization and gamma irradiation, ensuring compatibility with a variety of biopharmaceutical solvents, All molded components and sealing elements are free from colorants and adhere to Class VI and ISO 10993 biocompatibility standards, effectively minimizing leachables and extractables for safe and hygienic processing. Each filter undergoes rigorous dual integrity testing during production, employing two independent testing methods for quality assurance, guaranteeing a 100% factory pass rate, Certified under ISO 9001 quality management and GMP standards, these filters have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, with no animal-derived TSE/BSE risks. Validated by internationally recognized organizations such as SGS and NF, the Challenge IM Capsule Filters provide comprehensive and reliable filtration solutions for the entire biopharmaceutical process, making them a trusted choice among suppliers in China

    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
    0.55 MPa / 25℃
    0.1 MPa / 80℃

    Filter Dimensions

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

    Biosafety

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

    Sterilization

    Challenge Pore® PES capsule filter cable of be 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 & 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

    What are the primary applications for the PES capsule filter?

    The typical applications include prefiltration of cell culture media, buffer filtration, and protective pre-column / pre-ultrafiltration filtration.

    What is the chemical compatibility range of this filter?

    This filter features broad chemical compatibility, operating reliably within a pH range of 1 to 14.

    What are the sterilization limits for the Challenge Pore® PES capsule filter?

    It can be sterilized using high-temperature steam (121 °C for 30 minutes, up to 5 cycles) or through gamma irradiation within the range of 25–40 kGy.

    Does this filter meet biosafety standards?

    Yes, it is compliant with USP <87> Non-cytotoxic standards and meets USP <88> Class VI plastic biocompatibility requirements. The endotoxin level is restricted to <0.25 EU/mL.

    What materials are used in its construction?

    The filter membrane is made of Hydrophilic Polyethersulfone (PES), the inner/outer cage and capsule housing are made of Polypropylene (PP), and the vent O-ring is constructed from Silicone Rubber.

    What filtration accuracy options are available?

    The filtration accuracy configurations include 0.8+0.45μm, 1.0+0.65μm, and 1.0+0.8μm.