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

Introducing our innovative double-layer filtration solution, designed with reliability and efficiency in mind. This unique design ensures excellent bacterial and particulate retention, making it an ideal choice for various industries. Our filters boast broad chemical compatibility, capable of handling pH levels from 1 to 14, suitable for diverse applications. With extremely low extractables, you can trust our product to maintain the integrity of your processes, As a leading factory in China, we pride ourselves on delivering high-quality filtration products. Partner with us, one of the premier suppliers in the industry, to enhance your filtration needs and experience unmatched 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 (FAQ)

    What are the typical applications for ChallengePore® PES filters?

    ChallengePore® PES filters are widely used for the filtration of cell culture media, intermediate products, drug substances, serum, blood products, and final product sterilization.

    What are the maximum operating temperature and pressure limits?

    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 these filters meet international biological safety standards?

    Yes. The filters are non-cytotoxic, complying with USP <87> and USP <88> Class VI Biological Reactivity requirements for plastics. They also feature low endotoxin levels (< 0.25 EU/mL).

    How can ChallengePore® PES Capsule Filters be sterilized?

    ChallengePore® PES Capsule Filters can be sterilized using an autoclave (121°C, 30 min, 5 cycles) or through Gamma Irradiation (25-40 kGy).

    What sterilization options are available for PES Cartridge Filters?

    ChallengePore® PES Cartridge Filters support autoclave sterilization up to 130°C (30 min, 25 cycles) as well as Steam-in-Place (SIP) methods.

    What integrity tests are used for these filters?

    Filter integrity is verified and maintained through standard Bubble Point and Diffusion Flow testing procedures.