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Challenge HF® Hollow Fiber Cartridges

Challenge HF® Hollow Fiber Cartridges
Challenge Filair® PTFE High-Retention, High-Flux Hydrophobic Sterilizing-Grade Capsule Filters & Cartridges

Challenge Filair® PTFE High-Retention, High-Flux Hydrophobic Sterilizing-Grade Capsule Filters & Cartridges
Challenge Pore® PES High Mycoplasma Retention Hydrophilic Capsule Filters & Cartridges

Challenge Pore® PES High Mycoplasma Retention Hydrophilic Capsule Filters & Cartridges
Challenge Pore® PES Low Protein Binding Hydrophilic Sterilizing-Grade

Challenge Pore® PES Low Protein Binding Hydrophilic Sterilizing-Grade
Challenge Pore® PES Hydrophilic Capsule Filters & Cartridges

Challenge Pore® PES Hydrophilic Capsule Filters & Cartridges
Challenge Pore® PES Low Protein Binding Hydrophilic Capsule Filters & Cartridges

Challenge Pore® PES Low Protein Binding Hydrophilic Capsule Filters & Cartridges
Challenge Pore® PP High-Performance Clarification Capsules & Cartridges

Challenge Pore® PP High-Performance Clarification Capsules & Cartridges
Challenge Filair® PTFE Hydrophobic Sterile Filter with High Retention and High Throughput

Challenge Filair® PTFE Hydrophobic Sterile Filter with High Retention and High Throughput
Challenge Pore® PES Hydrophilic Filter with High Mycoplasma Retention

Challenge Pore® PES Hydrophilic Filter with High Mycoplasma Retention
Challenge Pore® PES Low-Protein-Binding Hydrophilic Sterile Filter

Challenge Pore® PES Low-Protein-Binding Hydrophilic Sterile Filter
0102030405

Challenge Pore® PES Filters: Low Protein-Binding, High-Quality China Suppliers & Factory Solutions for Biopharmaceuticals

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The Challenge IM Capsule Filters are expertly engineered by leading China suppliers, encompassing five essential series: clarification, pre-filtration & sterilizing-grade, sterile filtration, mycoplasma removal, and gas filtration. These filters boast particle retention capabilities ranging from 0.1 to 30 μm, designed to meet comprehensive process requirements from cell culture clarification to final product sterilization. Our filters support high-temperature steam sterilization and gamma irradiation, ensuring compatibility with a wide array of biopharmaceutical solvents. Manufactured in our state-of-the-art factory, all molded parts and sealing components are free of colorants and comply with Class VI and ISO 10993 biocompatibility standards, effectively minimizing leachables and extractables for hygienic processing. Each filter undergoes stringent dual integrity testing during production, with two independent test methods mandated for release, guaranteeing a 100% factory pass rate. The filters also adhere to ISO 9001 quality management and GMP standards, having successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, eliminating any TSE/BSE risks from animal-derived materials. Our products are validated by multiple internationally recognized agencies, including SGS and NF, delivering fully verified and reliable filtration solutions for the entire biopharmaceutical process.

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    Product Detail

    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 (Effective Filtration Area)

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

    Biosafety

    Test Item Specifications / Standards
    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 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 of these PES capsule filters?

    These filters are primarily designed for the prefiltration of cell culture media, buffer filtration, and protective pre-column or pre-ultrafiltration filtration processes.

    Can the Challenge Pore® PES capsule filters be sterilized?

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

    What is the chemical compatibility range of the membrane?

    The hydrophilic Polyethersulfone (PES) membrane features broad chemical compatibility, operating reliably within a pH range of 1 to 14.

    Are these capsule filters safe for biological applications?

    Yes, they are highly biocompatible. They meet USP <87> Non-cytotoxic standards, comply with USP <88> Class VI plastic biocompatibility requirements, and have endotoxin levels below 0.25 EU/mL.

    What are the maximum operating pressures and temperatures?

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

    What sizes and effective filtration areas are available?

    They are available in three main configurations: Size 01 (0.05 ㎡), Size 05 (0.28 ㎡), and Size 10 (0.55 ㎡).