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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

China Suppliers High-Performance Challenge Pore® PP Clarification Filter Factory for Biopharmaceutical Processes

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The Challenge IM Capsule Filters offer a comprehensive range tailored for the biopharmaceutical industry, covering five essential series: clarification, pre-filtration & sterilizing-grade, sterile filtration, mycoplasma removal, and gas filtration. With particle retention capabilities from 0.1 to 30 μm, these filters effectively meet the diverse process requirements from cell culture clarification to final product sterilization. As a leading supplier in China, our filters support high-temperature steam sterilization and gamma irradiation, ensuring compatibility with a wide variety of biopharmaceutical solvents. All molded parts and sealing components are free from colorants and fully comply with Class VI and ISO 10993 biocompatibility standards, significantly reducing leachables and extractables for hygienic processing. Every product is subjected to dual integrity testing during manufacturing, requiring two independent test methods for release, guaranteeing a 100% factory pass rate. Furthermore, our filters adhere to ISO 9001 quality management and GMP standards, passing rigorous tests including USP <85> endotoxin, USP <87>/<88> biocompatibility, and USP <665> extractables, with no animal-derived TSE/BSE risk. As a trusted China factory, we ensure validation by multiple internationally recognized agencies such as SGS and NF, delivering fully verified and reliable filtration solutions for every step of the biopharmaceutical process.

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    Product Detail

    Features

    • Constructed with multiple layers of polypropylene membranes of varying pore sizes, scientifically combined to provide high retention, high throughput, and excellent fouling capacity.

    Typical Applications

    • Prefiltration of cell culture media
    • Clarification of fermentation broth or cell culture fluids
    • Prefiltration of serum and blood products
    • Prefiltration of colloidal or viscous liquids

    Operating Conditions

    • Maximum operating temperature: 80℃
    • Maximum differential pressure: 0.55MPa/25℃, 0.1MPa/80℃

    Biosafety

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

    Filter Dimensions

    01: 0.04㎡
    02: 0.08㎡
    04: 0.15㎡
    05: 0.2㎡
    10: 0.4㎡

    Sterilization

    • Challenge Pore® PP capsule filter capable of up to 25 cycles of high-temperature steam sterilization

    Material Construction

    Component Material / Specification
    Filter Membrane Polypropylene (PP)
    Inner Cage, Outer Cage Polypropylene (PP)
    Capsule Housing Polypropylene (PP)
    Capsule Vent O-Ring Silicone Rubber
    Filtration Accuracy
    0.2μm 0.5μm 0.65μm 1.0μm 3.0μm 5.0μm 10μm 20μm 30μm

    Frequently Asked Questions

    What materials are used in the construction of the Challenge Pore® PP capsule filter?
    The filter membrane, inner cage, outer cage, and capsule housing are constructed from Polypropylene (PP). The capsule vent O-ring is made of Silicone Rubber.
    What are the typical applications for these capsule filters?
    Typical applications include the prefiltration of cell culture media, clarification of fermentation broth or cell culture fluids, prefiltration of serum and blood products, and the prefiltration of colloidal or viscous liquids.
    What are the maximum operating temperature and pressure limits?
    The maximum operating temperature is 80℃. The maximum differential pressure limit is 0.55MPa at 25℃ and 0.1MPa at 80℃.
    How many sterilization cycles can this capsule filter withstand?
    The Challenge Pore® PP capsule filter is capable of withstanding up to 25 cycles of high-temperature steam sterilization.
    Does the filter meet biocompatibility and biosafety standards?
    Yes, it has an endotoxin level of ＜ 0.25 EU/mL, is compliant with USP <87> Non-cytotoxic standards, and meets the USP <88> Class VI plastic biocompatibility requirements.
    What filtration accuracies and sizes are available?
    Filtration accuracies range from 0.2μm to 30μm (including 0.2, 0.5, 0.65, 1.0, 3.0, 5.0, 10, 20, and 30μm). Available filter dimensions (filtration areas) are 0.04㎡, 0.08㎡, 0.15㎡, 0.2㎡, and 0.4㎡.