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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 Challenge Pore® PP High-Performance Clarification Capsules & Cartridges for Efficient Filtration

Discover our scientifically engineered multi-layer filtration solution, crafted with premium Polypropylene (PP) membranes of varying pore sizes. This advanced design ensures exceptional retention efficiency, high throughput, and superior dirt holding capacity. As a leading factory in China, we pride ourselves on delivering top-quality filtration products. Choose us as your trusted suppliers for reliable and innovative solutions tailored to meet your filtration 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.
    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
    Q1: What sterilization methods are these products compatible with?
    They feature superior compatibility and are compatible with both Autoclave and Gamma irradiation.
    Q2: How does the pigment-free construction benefit the process?
    All plastic components, seals, and accessories are pigment-free, which minimizes the risk of extractables and leachables (E&L) for a more hygienic process. They are fully compliant with USP Class VI and ISO 10993 biocompatibility standards.
    Q3: What regulatory and testing standards are met for integrity assurance?
    The products operate 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 free from animal-derived components (TSE/BSE Free).
    Q4: Which testing agencies have validated these filters?
    Every batch meets international validation standards and is validated by world-leading agencies, including SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF.
    Q5: What are the typical applications for Challenge IM Capsule Filters?
    They are suitable for buffer filtration, intermediate product and drug substance filtration, terminal filtration, pre-filtration of cell culture media, clarification of fermentation broth or cell culture harvest, pre-filtration of serum and blood products, as well as pre-filtration of colloids or viscous fluids.
    Q6: Which specific executed standards are followed for testing bacterial retention and extractables?
    The filters are tested according to ASTM F838 for determining bacterial retention of membrane filters, USP <665> for extractables and leachables, and USP <87> & <88> for biological reactivity.