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

Discover our unique double-layer filter design, crafted by leading suppliers in China. This innovative product ensures reliable bacterial and particulate retention, making it an essential choice for various applications. With broad chemical compatibility that spans pH levels from 1 to 14, our filters are perfect for challenging environments. Additionally, they feature extremely low extractables, ensuring high purity and safety. Trust in our factory's commitment to quality and performance for all your filtration needs

    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 (FAQ)

    What are the primary applications of these filtration products?
    They are designed for cell culture media, intermediate products, drug substances, serum, blood products, and final product filtration.
    What is the maximum operating temperature allowed?
    The maximum operating temperature is 80°C.
    What are the endotoxin levels and biocompatibility standards?
    The endotoxin level is < 0.25 EU/mL. Biocompatibility complies with USP <87> (no cytotoxicity) and USP <88> Class VI biological reactivity requirements for plastics.
    How can ChallengePore® PES Capsule Filters be sterilized?
    Capsule filters can be sterilized using Autoclave (121°C, 30 min, 5 cycles) or Gamma Irradiation (25-40 kGy).
    Can ChallengePore® PES Cartridge Filters withstand Steam-in-Place (SIP)?
    Yes, Cartridge Filters support Steam-in-Place (SIP) as well as Autoclaving up to 130°C for 30 minutes across 25 cycles.
    Which integrity testing methods can be used?
    Integrity testing can be performed using standard Bubble Point and Diffusion Flow methods.