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China Suppliers Challenge Pore® PES Low Protein-Binding Filters - Reliable Biopharmaceutical Solutions from Factory

The Challenge IM Capsule Filters are designed to meet the rigorous demands of the biopharmaceutical industry, serving as an essential solution for various filtration needs. With five key series—clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration—these filters provide particle retention capabilities ranging from 0.1 to 30 µm. This extensive range meets all process requirements, from cell culture clarification to final product sterilization, Manufactured in our state-of-the-art factory in China, these filters support high-temperature steam sterilization and gamma irradiation, ensuring compatibility with a wide array of common biopharmaceutical solvents. All molded parts and sealing components are free from colorants, meeting Class VI and ISO 10993 biocompatibility standards, which minimizes leachables and extractables for hygienic processing, To guarantee quality, each filter undergoes dual integrity testing during production, employing two independent test methods to ensure a 100% factory pass rate. Additionally, the filters adhere to ISO 9001 quality management and GMP standards, having successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests while posing no animal-derived TSE/BSE risk, As leading suppliers in the biopharmaceutical sector, we ensure that all our products are validated by multiple internationally recognized agencies, such as SGS and NF, delivering reliable and verified filtration solutions for the entire biopharmaceutical process. Choose our Challenge IM Capsule Filters for exceptional performance and quality you can trust

    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

    01: 0.05㎡ 05: 0.28㎡ 10: 0.55㎡

    Sterilization

    • Challenge Pore® PES capsule filter 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

    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 (FAQ)

    1. What are the main features of the Challenge Pore® PES capsule filter?

    The filter features a unique dual-layer design, reliable bacteria and particle retention, broad chemical compatibility (pH 1-14), extremely low extractables, and low protein binding.

    2. What are the typical applications for this capsule filter?

    It is widely used for the prefiltration of cell culture media, buffer filtration, and protective pre-column / pre-ultrafiltration filtration.

    3. What sterilization methods are compatible with this filter?

    The filter can be sterilized using high-temperature steam (121 °C for 30 minutes, up to 5 cycles) or by gamma irradiation at 25–40 kGy.

    4. What materials are used in the construction of the filter?

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

    5. What are the maximum operating limits for pressure and temperature?

    The maximum operating temperature is 80℃. The maximum differential pressure limits are 0.55MPa at 25℃ and 0.1MPa at 80℃.

    6. Does the filter meet international biosafety standards?

    Yes. The filter is compliant with USP <87> Non-cytotoxic, meets USP <88> Class VI plastic biocompatibility requirements, and has endotoxin levels of < 0.25 EU/mL.