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Challenge Pore® PES Hydrophilic Filter: Top China Suppliers for Mycoplasma Retention Solutions from a Trusted Factory

The Challenge IM Capsule Filters are designed to meet the diverse needs of the biopharmaceutical industry, featuring five key series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration. With particle retention capabilities ranging from 0.1 to 30 µm, these filters provide comprehensive solutions from cell culture clarification to final product sterilization. They are engineered to support high-temperature steam sterilization and gamma irradiation, making them compatible with a wide array of biopharmaceutical solvents, As leading suppliers in China, our filters are manufactured with high standards. All molded parts and sealing components are free from colorants and comply with Class VI and ISO 10993 biocompatibility standards, ensuring minimal leachables and extractables for hygienic processing. To guarantee quality, each product undergoes dual integrity testing during production, requiring two independent test methods for release, which ensures a 100% factory pass rate, Our filters adhere to ISO 9001 quality management and GMP standards. They have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, eliminating any risk associated with animal-derived TSE/BSE. Additionally, all products are validated by multiple internationally recognized agencies such as SGS and NF, providing fully verified and reliable filtration solutions for the entire biopharmaceutical process. Trust our factory for high-quality filtration solutions in the biopharmaceutical sector

    Features

    • Unique dual-layer design
    • Reliable bacteria and particle retention
    • Broad chemical compatibility (pH 1-14)
    • Extremely low extractables

    Typical Application

    • Prefiltration of cell culture media
    • Filtration of intermediate, bulk
    • Filtration of serum and blood products
    • Sterile filtration of final products

    Operating Conditions

    • Maximum operating temperature: 80℃
    • Maximum differential pressure: 0.55MPa/25℃, 0.1MPa/80℃

    Filter Dimensions

    01: 0.05㎡
    02: 0.10㎡
    04: 0.20㎡
    05: 0.28㎡
    10: 0.55㎡ (0.1MPa/80℃)

    Biosafety

    Endotoxin <0.25 EU/mL
    Biocompatibility
    • Compliant with USP <87> Non-cytotoxic
    • Meets USP <88> Class VI plastic biocompatibility requirements

    Sterilization

    Challenge Pore® PES capsule filter cable of be sterilized by high-temperature steam (121 °C for 30 minutes, up to 5 cycles) or by gamma irradiation (25–40 kGy)

    Material Construction

    Filter Membrane Hydrophilic Polyethersulfone (PES)
    Inner Cage, Outer Cage Polypropylene (PP)
    Capsule Housing Polypropylene (PP)
    Capsule Vent O-Ring Silicone Rubber
    Filtration Accuracy 0.2+0.1μm

    Frequently Asked Questions

    What are the main features of the Challenge Pore® PES capsule filter?
    The filter features a unique dual-layer design, reliable bacteria and particle retention, broad chemical compatibility within a pH range of 1 to 14, and extremely low extractables.
    What are the typical applications for this capsule filter?
    It is typically used for the prefiltration of cell culture media, filtration of intermediates and bulk products, filtration of serum and blood products, and sterile filtration of final products.
    What are the maximum operating conditions for the filter?
    The maximum operating temperature is 80℃. The maximum differential pressure is 0.55MPa at 25℃ and 0.1MPa at 80℃.
    Does the filter meet international biosafety standards?
    Yes, it has endotoxin levels of <0.25 EU/mL. For biocompatibility, it is compliant with USP <87> Non-cytotoxic standards and meets USP <88> Class VI plastic biocompatibility requirements.
    How can the Challenge Pore® PES capsule filter be sterilized?
    It can be sterilized by high-temperature steam at 121 °C for 30 minutes (up to 5 cycles) or by gamma irradiation at a dosage of 25–40 kGy.
    What materials are used in the construction of this filter?
    The filter membrane is made of Hydrophilic Polyethersulfone (PES), the inner cage, outer cage, and capsule housing are made of Polypropylene (PP), and the capsule vent O-ring is constructed from Silicone Rubber.