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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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China Suppliers Factory for Challenge Pore® PES Hydrophilic Capsule Filters & Cartridges – High Flow, Reliable Retention

Our product offers reliable bacteria and particulate retention, ensuring high flow rates and exceptional throughput. As a leading supplier and factory in China, we provide solutions that are compatible with a wide range of chemicals, making us your ideal partner for efficient and effective filtration. Trust us for high-quality performance and innovative products tailored to your needs
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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)
    Typical Applications
    • Pre-filtration of cell culture media
    • Buffer filtration
    0.45um Pre-filtration Capsule Filters Flow Rate Performance
    0.45um Pre-filtration Capsule Filters Flow Rate Performance Graph
    Frequently Asked Questions
    What sterilization methods are these capsule filters compatible with?
    These filters feature superior compatibility and are fully compatible with both Autoclave and Gamma irradiation sterilization processes.
    How does the pigment-free construction benefit the manufacturing process?
    All plastic components, seals, and accessories are completely pigment-free. This design minimizes the risk of extractables and leachables (E&L) to ensure a more hygienic process, fully complying with USP Class VI and ISO 10993 biocompatibility standards.
    What quality systems and regulations do these filters comply with?
    Our manufacturing operates under an ISO 9001 quality system and complies with GMP regulations. The products meet stringent testing standards, including USP <85> for Bacterial Endotoxins, USP <87> & <88> for Biocompatibility, USP <665> for Extractables, and are verified free from animal-derived components (TSE/BSE Free).
    Which independent agencies validate the quality of these capsule filters?
    Our products are validated by world-leading testing and certification agencies, such as SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF, ensuring every production batch meets international validation standards.
    What are the typical applications for Challenge IM Capsule Filters?
    They are specifically designed for the biopharmaceutical industry. Typical applications include the pre-filtration of cell culture media, buffer filtration, intermediate product and drug substance filtration, as well as terminal filtration.