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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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Low Protein Binding Hydrophilic Capsule Filters & Cartridges - China Suppliers & Factory Solutions for Bioprocessing

Challenge IM offers a complete range of capsule filters designed to meet the diverse needs of the bioprocessing industry. Our product lineup includes Clarification, Pre-filtration & Bioburden Reduction, Sterilizing-grade, Mycoplasma Removal, and Gas Filtration series. With retention capabilities ranging from 0.1μm to 30μm, our solutions seamlessly support every step of the bioprocess workflow—from cell culture clarification to final product sterilization. As a leading supplier and factory in China, we are committed to delivering high-quality filtration solutions that enhance efficiency and ensure the safety of your biopharmaceutical products. Choose Challenge IM for reliable filtration systems that meet the rigorous standards of today's bioprocessing demands
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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, these capsule filters are fully compatible with both Autoclave sterilization and Gamma irradiation processing.
    How does the pigment-free construction benefit biopharmaceutical applications?
    By ensuring all plastic components, seals, and accessories are pigment-free, the risk of extractables and leachables (E&L) is minimized. This guarantees a more hygienic process compliant with USP Class VI and ISO 10993 standards.
    What quality standards and regulations do these filters meet?
    Our products are manufactured under an ISO 9001 and GMP-compliant quality system. They meet testing standards including USP <85> (Bacterial Endotoxins), USP <87> & <88> (Biocompatibility), USP <665> (Extractables), and are certified TSE/BSE Free.
    Who validates the performance of Challenge IM Capsule Filters?
    Every batch of filters is validated by world-leading independent testing agencies, such as SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF, to ensure compliance with international validation standards.
    What are the core features of these capsule filters?
    Key features include a unique double-layer design, reliable bacterial and particulate retention, broad chemical compatibility (pH 1-14), extremely low extractables, and low protein binding.