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High Mycoplasma Retention Capsule Filters & Cartridges - China Suppliers & Factory | Challenge Pore® PES Filters

Introducing our innovative double-layer filtration solution, designed with a unique structure to ensure reliable bacterial and particulate retention. Our product offers exceptional chemical compatibility, making it suitable for a pH range of 1-1With extremely low extractables, it guarantees purity and safety for various applications. As a leading supplier in China, our factory utilizes state-of-the-art technology to deliver high-quality filtration solutions tailored to meet your needs. Trust our product for effective filtration and unparalleled performance

    Typical Applications
    Filtration of cell culture media
    Intermediate product and drug substance filtration
    Filtration of serum and blood products
    Final product filtration
    Product Specifications
    [Working Conditions]
    Max. Operating Temp: 80°C
    Max. Operating DP: 0.55 MPa @ 25°C / 0.1 MPa @ 80°C
    [Biological Safety]
    Endotoxin: < 0.25 EU/mL
    Biocompatibility: Complies with USP <87>, No potential cytotoxicity
    Complies with USP <88> Class VI Biological Reactivity requirements for plastics
    Integrity Test: Bubble Point and Diffusion Flow
    [ Sterilization Methods ]
    ChallengePore® PES Capsule Filters: Autoclave (121°C, 30 min, 5 cycles) or Gamma Irradiation (25-40 kGy).
    ChallengePore® PES Cartridge Filters: Autoclave (up to 130°C, 30 min, 25 cycles) and Steam-in-Place (SIP).
    Frequently Asked Questions
    What are the typical applications for these PES filters?
    These filters are typically used for the filtration of cell culture media, intermediate products, drug substances, serum, blood products, and final product filtration.
    What is the maximum operating temperature and pressure?
    The maximum operating temperature is 80°C. The maximum operating differential pressure (DP) is 0.55 MPa at 25°C and 0.1 MPa at 80°C.
    Do the filters comply with biocompatibility and safety standards?
    Yes. The filters have an endotoxin level of less than 0.25 EU/mL. They comply with USP <87> for cytotoxicity and USP <88> Class VI biological reactivity requirements for plastics.
    How are ChallengePore® PES Capsule Filters sterilized?
    They can be sterilized using an autoclave (121°C for 30 minutes, up to 5 cycles) or through Gamma Irradiation (25-40 kGy).
    What sterilization methods are compatible with ChallengePore® PES Cartridge Filters?
    They can undergo autoclave sterilization (up to 130°C for 30 minutes, up to 25 cycles) and Steam-in-Place (SIP) processing.
    How is the integrity of these filters tested?
    The integrity of the filters is verified using Bubble Point and Diffusion Flow testing methods.