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High-Flow Hydrophilic Filters from China Suppliers | Challenge Pore® PES Factory for Biopharmaceutical Processes

The Challenge IM Capsule Filters are expertly designed to meet the diverse needs of the biopharmaceutical industry with five essential series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration. Our filters offer a particle retention range from 0.1 to 30 μm, ensuring comprehensive solutions from cell culture clarification to final product sterilization. Manufactured by trusted suppliers in China, these high-quality filters support high-temperature steam sterilization and gamma irradiation while being compatible with a broad array of commonly used biopharmaceutical solvents, Each component of the filters, including molded parts and sealing elements, is free from colorants and adheres to Class VI and ISO 10993 biocompatibility standards. This guarantees minimal leachables and extractables, thereby ensuring hygienic processing. We take pride in the rigorous quality assurance process, where each product undergoes dual integrity testing during production. With two independent test methods required for release, we guarantee a 100% factory pass rate, Our filters comply with ISO 9001 quality management and GMP standards, successfully passing USP endotoxin, USP / biocompatibility, and USP extractables tests, all while posing no TSE/BSE risk from animal-derived materials. Validated by multiple internationally recognized agencies, including SGS and NF, our filters are your reliable choice for verified filtration solutions throughout the entire biopharmaceutical process. Choose Challenge IM Capsule Filters to ensure the highest standards for your production needs

    Features

    • Reliable bacteria and particle retention
    • Broad chemical compatibility
    • High flow rate
    • High throughput

    Typical Application

    • Prefiltration of cell culture media
    • Buffer filtration

    Operating Conditions

    Maximum Operating Temperature 80℃
    Maximum Differential Pressure 0.55MPa / 25℃
    0.1MPa / 80℃

    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 0.45μm / 0.65μm / 0.8μm

    Biosafety

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

    Dimension

    Disc Filter D50: 20cm²
    Capsule Filter 01: 0.075m  02: 0.14m  04: 0.25m  05: 0.34m  10: 0.68m
    * Challenge Filair® PTFE filter cable of up to 50 cycles of high-temperature steam sterilization.

    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)

    0.45μm Pre-Filtration Capsule Filter Flow Rate

    0.45μm Pre-Filtration Capsule Filter Flow Rate Diagram
    Differential Pressure
    Flow Rate at 20 °C: (L/min)

    Frequently Asked Questions

    What are the typical applications for this filter?

    Typical applications include the prefiltration of cell culture media and buffer filtration.

    What are the operating temperature and pressure limits?

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

    What materials are used in the construction of the capsule 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.

    Does the filter meet biosafety standards?

    Yes. The filter has endotoxin levels of <0.25 EU/mL, 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 25–40 kGy.

    What filtration accuracies and sizes are available?

    Filtration accuracies are available in 0.45μm, 0.65μm, and 0.8μm. Dimensions include Disc Filters (D50: 20cm²) and Capsule Filters in sizes 01 (0.075m), 02 (0.14m), 04 (0.25m), 05 (0.34m), and 10 (0.68m).