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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
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Challenge Pore® PES Low Protein Binding Hydrophilic Capsule Filters & Cartridges from Leading China Suppliers and Factory

Challenge IM offers an extensive range of high-quality capsule filters, including Clarification, Pre-filtration & Bioburden Reduction, Sterilizing-grade, Mycoplasma Removal, and Gas Filtration series. With retention capabilities from 0.1μm to 30μm, our filters cater to the complete bioprocess workflow—from cell culture clarification to final product sterilization. As a leading manufacturer and supplier in China, our factory is committed to providing reliable filtration solutions that enhance the efficiency of your bioprocessing needs. Choose Challenge IM for innovative products that ensure purity and safety in every stage of production
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    Product Detail

    Superior Compatibility
    Compatible with both Autoclave and Gamma irradiation.
    Highly compatible with a wide range of common solvents used in biopharmaceutical manufacturing.
    Pigment-Free Construction
    All plastic components, seals, and accessories are pigment-free, minimizing the risk of extractables and leachables (E&L) for a more hygienic process. Fully compliant with USP Class VI and ISO 10993 biocompatibility standards.
    100% Integrity Assurance
    Through rigorous process controls and stringent factory release testing, we ensure a 100% qualification rate for all outgoing products.
    Robust Quality System:
    Operating under ISO 9001 and compliant with GMP regulations; Meets stringent testing standards including: Bacterial Endotoxins: USP <85>, Biocompatibility: USP <87> & <88>, Extractables: USP <665>, Free from animal-derived components (TSE/BSE Free).
    Validated Excellence
    Products are validated by world-leading agencies such as SGS and NF, ensuring every batch meets international validation standards.
    Challenge IM Capsule Filters are specifically designed for the biopharmaceutical industry. They are suitable for applications such as buffer filtration, intermediate product and drug substance filtration, as well as terminal filtration. This product has passed multiple tests conducted by the internationally recognized testing agency: SGS (SGS-CSTC Standards Technical Services Co., Ltd.).
    Partial List of Executed Standards
    ASTM F838: Standard Test Method for Determining Bacterial Retention of Membrane Filters for Liquids
    USP <665>: United States Pharmacopeia: Extractables and Leachables (E&L) Testing in Biopharmaceutical Production
    USP <87>: Biological Reactivity Tests, In Vitro.
    USP <88>: Biological Reactivity Tests, In Vivo (Class VI)
    Product Features
    Unique double-layer design
    Reliable bacterial and particulate retention
    Broad chemical compatibility, pH 1-14
    Extremely low extractables
    Low protein binding
    Typical Applications
    Pre-filtration of cell culture media
    Buffer filtration
    Pre-column / Pre-ultrafiltration protection
    Frequently Asked Questions
    Are Challenge IM Capsule Filters compatible with autoclave sterilization?
    Yes, Challenge IM Capsule Filters feature superior compatibility and are fully compatible with both Autoclave and Gamma irradiation sterilization methods.
    What does pigment-free construction mean for my processes?
    All plastic components, seals, and accessories are pigment-free. This minimizes the risk of extractables and leachables (E&L), ensuring a highly hygienic process that is fully compliant with USP Class VI and ISO 10993 biocompatibility standards.
    How do you guarantee the quality of each filter?
    We operate under a robust quality system compliant with ISO 9001 and GMP regulations. Through rigorous process controls and stringent factory release testing, we ensure a 100% integrity qualification rate for all outgoing products.
    Which international standards do these filters comply with?
    Our filters meet and are tested against key industry standards, including ASTM F838 (bacterial retention), USP <665> (E&L testing), USP <87> & <88> (biocompatibility), and USP <85> (bacterial endotoxins). They are also certified TSE/BSE free.
    What are the primary applications for Challenge IM Capsule Filters?
    They are typically used in the biopharmaceutical industry for applications such as pre-filtration of cell culture media, buffer filtration, pre-column/pre-ultrafiltration protection, intermediate product and drug substance filtration, and terminal filtration.