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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 - Challenge Pore® PES Low Protein Binding Hydrophilic Capsule Filters & Cartridges Factory

Challenge IM offers an extensive range of high-quality capsule filters, catering to various filtration needs, including Clarification, Pre-filtration & Bioburden Reduction, Sterilizing-grade, Mycoplasma Removal, and Gas Filtration series. With a broad retention range from 0.1μm to 30μm, our solutions are ideal for the complete bioprocess workflow, from cell culture clarification to final product sterilization. As a leading factory and supplier in China, we are committed to providing innovative filtration solutions that meet the needs of the biopharmaceutical industry
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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
    Q1 Are Challenge IM Capsule Filters compatible with gamma sterilization?
    Yes, they feature superior compatibility and are fully compatible with both Autoclave and Gamma irradiation sterilization processes.
    Q2 How does the pigment-free construction benefit biopharmaceutical processing?
    The pigment-free design of all plastic components, seals, and accessories minimizes the risk of extractables and leachables (E&L), ensuring a highly hygienic process compliant with USP Class VI and ISO 10993 standards.
    Q3 What quality standards do these capsule filters comply with?
    The filters are manufactured under an ISO 9001 and GMP-compliant Quality System. They meet standards including USP <85> (Bacterial Endotoxins), USP <87> & <88> (Biocompatibility), USP <665> (Extractables), and are completely TSE/BSE Free.
    Q4 What are the primary applications for Challenge IM Capsule Filters?
    They are typically used for the pre-filtration of cell culture media, buffer filtration, intermediate and drug substance filtration, terminal filtration, as well as pre-column and pre-ultrafiltration protection.
    Q5 What chemical compatibility range do these filters offer?
    Challenge IM Capsule Filters provide broad chemical compatibility across a wide pH range of 1-14, making them highly compatible with common solvents used in biopharmaceutical manufacturing.
    Q6 Have these products been validated by independent testing agencies?
    Yes, they are validated by world-leading testing agencies such as SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF, ensuring compliance with international validation standards.