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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 - Efficient Filtration at Our Factory

Discover our advanced multi-layer filtration system, meticulously crafted with scientifically graded Polypropylene (PP) membranes. These membranes feature varying pore sizes, ensuring exceptional retention efficiency, high throughput, and impressive dirt holding capacity. As a leading factory and supplier in China, we are committed to providing high-quality filtration solutions tailored to meet diverse industrial needs. Enhance your operations with our innovative products, designed for optimal performance and reliability
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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
    What sterilization methods are Challenge IM Capsule Filters compatible with?
    They feature superior compatibility and are compatible with both Autoclave and Gamma irradiation sterilization processes.
    How does pigment-free construction benefit biopharmaceutical processing?
    All plastic components, seals, and accessories are completely pigment-free. This minimizes the risk of extractables and leachables (E&L), ensuring a more hygienic process that is fully compliant with USP Class VI and ISO 10993 biocompatibility standards.
    What quality standards do these capsule filters comply with?
    Our filters operate under ISO 9001 and comply with GMP regulations. They meet stringent testing standards including USP <85> for Bacterial Endotoxins, USP <87> & <88> for Biocompatibility, USP <665> for Extractables, and are certified free from animal-derived components (TSE/BSE Free).
    Which third-party agencies validate these filtration products?
    The products are validated by world-leading testing and certification agencies, including SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF, ensuring every batch meets international 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. They are also suitable for buffer filtration, intermediate product and drug substance filtration, as well as terminal filtration.
    Which standards are executed for testing bacterial retention and extractables?
    The executed standards include ASTM F838 for determining bacterial retention of membrane filters, USP <665> for extractables and leachables (E&L) testing, and USP <87> & <88> (Class VI) for biological reactivity testing.