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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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High-Performance PP Clarification Capsules & Cartridges from China Suppliers | Factory Direct Quality

Discover our advanced multi-layer filtration system crafted with precision in China. Our factory employs scientifically graded Polypropylene (PP) membranes of varying pore sizes, ensuring high retention efficiency and exceptional throughput. As one of the leading suppliers, we pride ourselves on our products' high dirt holding capacity, making them ideal for a variety of applications. Experience reliable filtration solutions that meet the highest industry standards
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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.
    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
    • Clarification of fermentation broth or cell culture harvest
    • Pre-filtration of serum and blood products
    • Pre-filtration of colloids or viscous fluids

    Frequently Asked Questions (FAQ)

    Are these capsule filters compatible with autoclave sterilization?

    Yes, the filters feature superior compatibility and are fully compatible with both Autoclave and Gamma irradiation sterilization methods.

    What makes the construction of these filters safe for biopharmaceutical use?

    They feature a pigment-free construction for all plastic components, seals, and accessories. This minimizes the risk of extractables and leachables (E&L) for a more hygienic process, fully complying with USP Class VI and ISO 10993 biocompatibility standards.

    What quality standards and regulations do these filters comply with?

    Our filters are manufactured under ISO 9001 and are compliant with GMP regulations. They meet stringent testing standards including USP <85> (Bacterial Endotoxins), USP <87> & <88> (Biocompatibility), USP <665> (Extractables), and are completely free from animal-derived components (TSE/BSE Free).

    Which third-party agencies have validated these filters?

    The products are validated by world-leading international agencies such as SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF, ensuring every production batch meets strict validation standards.

    What are the typical applications for Challenge IM Capsule Filters?

    Typical applications include the pre-filtration of cell culture media, clarification of fermentation broth or cell culture harvest, pre-filtration of serum and blood products, and pre-filtration of colloids or viscous fluids.

    What specific standards are executed during testing?

    Executed standards include ASTM F838 for determining bacterial retention of membrane filters, USP <665> for Extractables and Leachables (E&L) testing, USP <87> for In Vitro biological reactivity, and USP <88> for In Vivo biological reactivity (Class VI).