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Challenge HF® Hollow Fiber Cartridges

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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 Low Protein-Binding Hydrophilic Filters - China Factory Suppliers for Biopharmaceutical Filtration Solutions

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The Challenge IM Capsule Filters are designed to meet the diverse needs of the biopharmaceutical industry, covering five essential series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration. With particle retention ranging from 0.1 to 30 µm, these filters serve all process requirements from cell culture clarification to final product sterilization. Manufactured in China, our factory produces filters that support high-temperature steam sterilization and gamma irradiation, compatible with a wide range of commonly used biopharmaceutical solvents. All molded parts and sealing components are free from colorants and adhere to Class VI and ISO 10993 biocompatibility standards, ensuring minimal leachables and extractables for hygienic processing. Each product undergoes dual integrity testing during production with two independent test methods required for release, guaranteeing 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, posing no animal-derived TSE/BSE risk. As leading suppliers in filtration solutions, we take pride in our products being validated by multiple internationally recognized agencies such as SGS and NF, ensuring 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: 0.55MPa/25℃, 0.1MPa/80℃

    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).

    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㎡

    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)

    Q1: What is the chemical compatibility range of the PES capsule filter?

    The filter offers broad chemical compatibility, performing reliably across a pH range of 1 to 14.

    Q2: How can the Challenge Pore® PES capsule filters be sterilized?

    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 of 25–40 kGy.

    Q3: Does this filter meet international biosafety standards?

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

    Q4: What materials are used to construct the capsule housing and filter membrane?

    The filter membrane is made of Hydrophilic Polyethersulfone (PES), while the capsule housing, inner cage, and outer cage are constructed from Polypropylene (PP).

    Q5: What are the maximum operating pressure limits for this filter?

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

    Q6: What filtration area options are available for this capsule filter?

    It is available in three distinct filtration sizes: 0.05㎡ (Model 01), 0.28㎡ (Model 05), and 0.55㎡ (Model 10).