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China Suppliers Factory Challenge Pore® PES Hydrophilic Capsule Filters & Cartridges for Reliable Bacteria Retention

Discover our high-quality filtration solutions designed for optimal bacteria and particulate retention. Our products boast broad chemical compatibility, ensuring versatility across various applications. With impressive flow rates and high throughput capabilities, they are ideal for industries seeking reliable performance. As a leading factory in China, we work with top suppliers to deliver innovative filtration technologies that meet your specific needs. Trust us for effective solutions that enhance your processes and ensure superior quality

    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 Chart
    Frequently Asked Questions (FAQ)
    Are Challenge IM Capsule Filters compatible with gamma irradiation?
    Yes, Challenge IM Capsule Filters are fully compatible with both Autoclave and Gamma irradiation sterilization processes.
    What is the advantage of pigment-free construction in these filters?
    The pigment-free construction of all plastic components, seals, and accessories minimizes the risk of extractables and leachables (E&L), ensuring a highly hygienic process that is fully compliant with USP Class VI and ISO 10993 biocompatibility standards.
    Which quality testing standards do these capsule filters meet?
    Our filters operate under ISO 9001 and GMP regulations. They meet stringent standards including USP <85> (Bacterial Endotoxins), USP <87> & <88> (Biocompatibility), and USP <665> (Extractables). Additionally, they are completely free from animal-derived components (TSE/BSE Free).
    Who validates the performance of Challenge IM Capsule Filters?
    Our products are validated by world-leading testing and certification agencies, such as SGS and NF, ensuring that every batch complies with international validation standards.
    What are the typical applications for these capsule filters?
    They are designed for the biopharmaceutical industry and are ideal for pre-filtration of cell culture media, buffer filtration, intermediate product and drug substance filtration, as well as terminal filtration.