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

The Challenge IM Capsule Filters are designed to meet the comprehensive filtration needs of the biopharmaceutical industry. Covering five essential series—clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration—our filters offer particle retention from 0.1 to 30 μm. They cater to the entire process, from cell culture clarification to final product sterilization, Manufactured in our state-of-the-art factory in China, these filters are engineered to withstand high-temperature steam sterilization and gamma irradiation while being compatible with various biopharmaceutical solvents. All molded parts and sealing components are free from colorants and adhere to Class VI and ISO 10993 biocompatibility standards, ensuring minimal leachables and extractables for hygienic processing, As leading suppliers in the industry, we guarantee that each product undergoes rigorous dual integrity testing during production, with two independent test methods required for release, resulting in a 100% factory pass rate. Our filters comply with ISO 9001 quality management and GMP standards, and have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, with no risk of animal-derived TSE/BSE, Trust our products, validated by multiple internationally recognized agencies such as SGS and NF, for reliable and efficient filtration solutions throughout your biopharmaceutical processes

    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 0.55 MPa / 25℃
    0.1 MPa / 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 is 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 + 0.1 μm

    Frequently Asked Questions

    What are the primary applications of the Challenge Pore® PES capsule filter?

    Typical applications include the prefiltration of cell culture media, filtration of intermediates and bulk products, filtration of serum and blood products, and sterile filtration of final biological products.

    What sterilization methods can be used with this capsule filter?

    The filter is fully compatible with sterilization by high-temperature steam (at 121 °C for 30 minutes, for up to 5 cycles) or by gamma irradiation within the range of 25–40 kGy.

    What materials are used in the construction of the filter?

    The filter membrane is made of Hydrophilic Polyethersulfone (PES). The inner/outer cages and capsule housing are constructed from Polypropylene (PP), and the capsule vent O-ring is made from Silicone Rubber.

    Does the filter meet international biosafety standards?

    Yes. The filter is compliant with USP <87> Non-cytotoxic standards and meets the USP <88> Class VI plastic biocompatibility requirements. It also maintains endotoxin levels below 0.25 EU/mL.

    What are the maximum operating pressure and temperature limits?

    The maximum operating temperature is 80℃. The maximum differential pressure limit is 0.55 MPa at 25℃ and decreases to 0.1 MPa at 80℃.

    What is the filtration accuracy of the membrane?

    The filtration accuracy of the dual-layer Hydrophilic Polyethersulfone (PES) membrane is rated at 0.2 + 0.1 μm.