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

Introducing our high-performance filtration solutions, designed for reliable bacteria and particulate retention. Our products offer broad chemical compatibility, ensuring they meet the diverse needs of various applications. With impressive flow rates and exceptional throughput, our filters are perfect for industries looking for efficiency and effectiveness. As a leading factory in China, we pride ourselves on delivering top-quality products that meet the highest industry standards. Trust our suppliers to provide you with the best filtration solutions for your needs

    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 Curve
    Frequently Asked Questions (FAQ)
    Are Challenge IM Capsule Filters compatible with autoclave sterilization?
    Yes, Challenge IM Capsule Filters feature superior compatibility and are fully compatible with both Autoclave and Gamma irradiation sterilization processes.
    What is the benefit of a pigment-free construction?
    The pigment-free construction of all plastic components, seals, and accessories minimizes the risk of extractables and leachables (E&L), ensuring a more hygienic process compliant with USP Class VI and ISO 10993 standards.
    What quality standards do these capsule filters comply with?
    They operate under a robust ISO 9001 and GMP-compliant quality system. They meet USP <85> for Bacterial Endotoxins, USP <87> & <88> for Biocompatibility, USP <665> for Extractables, and are certified TSE/BSE Free.
    Which independent agencies have validated these filters?
    Challenge IM Capsule Filters are validated by world-leading international testing agencies, including SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF.
    What are the typical applications for these capsule filters?
    They are designed for the biopharmaceutical industry and are typically used for the pre-filtration of cell culture media, buffer filtration, intermediate product and drug substance filtration, as well as terminal filtration.