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China Challenge Pore® PES High-Flow Hydrophilic Filters - Trusted Suppliers and Factory for Biopharmaceutical Filtration Solutions

The Challenge IM Capsule Filters are a comprehensive solution designed for the biopharmaceutical industry, encompassing five essential series: clarification, pre-filtration & sterilizing-grade, sterile filters, mycoplasma removal, and gas filtration. With particle retention from 0.1 to 30 µm, these filters cater to all process requirements, from cell culture clarification to final product sterilization, Manufactured in our advanced factory in China, these filters are built to support high-temperature steam sterilization and gamma irradiation, ensuring compatibility with a broad spectrum of commonly utilized biopharmaceutical solvents. All molded parts and sealing components are free of colorants and adhere to Class VI and ISO 10993 biocompatibility standards, reducing leachables and extractables for hygienic processing, Each product undergoes rigorous dual integrity testing during production, incorporating two independent testing methods for release to guarantee a 100% factory pass rate. Our filters meet ISO 9001 quality management and GMP standards, and have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, all while posing no risk of animal-derived TSE/BSE, As a leading supplier in the biopharmaceutical field, our products are validated by internationally recognized agencies such as SGS and NF, assuring clients of fully verified and reliable filtration solutions throughout the entire biopharmaceutical process. Choose our Challenge IM Capsule Filters for superior quality and performance in your operations

    Features

    Reliable bacteria and particle retention

    Broad chemical compatibility

    High flow rate

    High throughput

    Typical Application

    Prefiltration of cell culture media

    Buffer filtration

    Operating Conditions

    Parameter Specification
    Maximum operating temperature 80℃
    Maximum differential pressure 0.55MPa/25℃, 0.1MPa/80℃

    Material Construction

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

    Biosafety

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

    Dimension

    Product Type Specification Details
    Disc Filter D50: 20cm²
    Capsule Filter 01: 0.075m²   02: 0.14m²   04: 0.25m²   05: 0.34m²   10: 0.68m²
    * Challenge Filair® PTFE filter cable of up to 50 cycles of high-temperature steam sterilization.

    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)

    0.45μm Pre-Filtration Capsule Filter Flow Rate

    filter 3 diagram

    Differential Pressure

    Flow Rate at 20 °C: (L/min)

    Frequently Asked Questions

    What are the primary applications of this PES capsule filter?
    This filter is typically used for the prefiltration of cell culture media and buffer filtration in laboratory and industrial processes.
    What are the maximum operating temperature and pressure limits?
    The filter can operate at a maximum temperature of 80℃. The maximum differential pressure limit is 0.55MPa at 25℃ and 0.1MPa at 80℃.
    What materials are used to construct the capsule filter?
    The membrane is made of Hydrophilic Polyethersulfone (PES), the inner/outer cages and capsule housing are constructed from Polypropylene (PP), and the capsule vent O-ring is made of Silicone Rubber.
    What filtration accuracies are available for these filters?
    The filters are available in three filtration accuracies: 0.45μm, 0.65μm, and 0.8μm.
    How can the Challenge Pore® PES capsule filter be sterilized?
    It can be sterilized by high-temperature steam at 121 °C for 30 minutes (up to 5 cycles) or by gamma irradiation at a dose of 25–40 kGy.
    Does this filter meet biosafety and biocompatibility standards?
    Yes, it has endotoxin levels of <0.25 EU/mL, complies with USP <87> Non-cytotoxic standards, and meets USP <88> Class VI plastic biocompatibility requirements.