zh-cn
  • sns01-1
  • sns04-1
  • sns02-1
Leave Your Message
Products Categories
Featured Products
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
0102030405
17.jpg

China Suppliers Factory: Challenge Pore® PES Low Protein Binding Hydrophilic Capsule Filters & Cartridges for Bioprocessing

,

Challenge IM is a leading China supplier and factory of a comprehensive range of capsule filters designed for various applications. Our portfolio includes Clarification, Pre-filtration & Bioburden Reduction, Sterilizing-grade, Mycoplasma Removal, and Gas Filtration series. With a diverse retention range from 0.1μm to 30μm, our filtration solutions are engineered to support the entire bioprocess workflow, from cell culture clarification to the final product sterilization. Partner with us for high-quality filtration systems that meet your bioprocess needs.

,
    Contact us
    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
    What sterilization methods are these capsule filters compatible with?
    Challenge IM Capsule Filters offer superior compatibility and are fully compatible with both Autoclave sterilization and Gamma irradiation.
    Why is a pigment-free construction important for capsule filters?
    A pigment-free construction ensures that all plastic components, seals, and accessories minimize the risk of extractables and leachables (E&L), creating a much safer and more hygienic process compliant with USP Class VI and ISO 10993 biocompatibility standards.
    What standards does your quality system meet?
    Our robust quality system operates under ISO 9001 and is compliant with GMP regulations. Our products meet stringent testing standards including USP <85> for Bacterial Endotoxins, USP <87> & <88> for Biocompatibility, USP <665> for Extractables, and are completely free from animal-derived components (TSE/BSE Free).
    Which testing agencies validate these capsule filters?
    Our products are validated by world-leading international testing agencies, including SGS (SGS-CSTC Standards Technical Services Co., Ltd.) and NF, ensuring every batch conforms to global requirements.
    What is the chemical compatibility and pH range of these filters?
    These filters feature exceptionally broad chemical compatibility, making them suitable for use across a wide pH range of 1 to 14, as well as with common solvents used in biopharmaceutical manufacturing.
    What are the typical applications for Challenge IM Capsule Filters?
    They are specifically designed for the biopharmaceutical industry and are ideal for applications such as pre-filtration of cell culture media, buffer filtration, intermediate product and drug substance filtration, terminal filtration, and pre-column / pre-ultrafiltration protection.