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High Mycoplasma Retention Challenge Pore® PES Hydrophilic Filter - Trusted China Suppliers & Factory Solutions

The Challenge IM Capsule Filters, a top product from leading China suppliers, encompass five essential series: clarification, pre-filtration & sterilizing-grade, sterile filtration, mycoplasma removal, and gas filtration. With particle retention capabilities ranging from 0.1 to 30 µm, these filters efficiently meet the complete process requirements—from cell culture clarification to final product sterilization. Designed for high-temperature steam sterilization and gamma irradiation, they are compatible with a wide array of biopharmaceutical solvents. Every molded part and sealing component is free from colorants, adhering to Class VI and ISO 10993 biocompatibility standards. This ensures minimal leachables and extractables, providing hygienic processing solutions. Each filter undergoes a rigorous dual integrity testing process during production, requiring two independent test methods for release, guaranteeing a 100% factory pass rate. Our filters also comply with ISO 9001 quality management and GMP standards, and have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, ensuring no animal-derived TSE/BSE risk. All products receive validation from multiple internationally recognized agencies, including SGS and NF, delivering verified and reliable filtration solutions for the entire biopharmaceutical process. Choose our Challenge IM Capsule Filters for high-quality, trustworthy filtration from a reputable China factory

    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℃

    Biosafety

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

    Filter Dimensions

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

    Sterilization

    Challenge Pore® PES capsule filter capable of being 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 key features of the Challenge Pore® PES capsule filter?
    The filter features a unique dual-layer design, reliable bacteria and particle retention, broad chemical compatibility (pH 1-14), 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 materials, filtration of serum and blood products, and sterile filtration of final products.
    What are the maximum operating pressure and temperature limits?
    The maximum operating temperature is 80℃. The maximum differential pressure is 0.55MPa at 25℃ and 0.1MPa at 80℃.
    Does this filter meet biosafety standards?
    Yes, it meets 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 using high-temperature steam (121 °C for 30 minutes, up to 5 cycles) or by gamma irradiation (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 constructed from Polypropylene (PP), and the capsule vent O-ring is made of Silicone Rubber.