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High-Quality Challenge Pore® PES Filters from China Factory | Trusted Suppliers for Biopharmaceutical Solutions

The Challenge IM Capsule Filters are a versatile solution provided by leading China suppliers, encompassing five essential series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration. With particle retention from 0.1 to 30 μm, these filters are designed to meet every process requirement, from cell culture clarification to final product sterilization. Manufactured in a state-of-the-art factory, the filters support high-temperature steam sterilization and gamma irradiation, making them compatible with a wide range of biopharmaceutical solvents, All molded parts and sealing components are free from colorants and adhere to Class VI and ISO 10993 biocompatibility standards, effectively minimizing leachables and extractables to ensure hygienic processing. Each filter undergoes rigorous dual integrity testing during production, requiring two independent testing methods for release, guaranteeing a 100% factory pass rate, Our filters meet ISO 9001 quality management and GMP standards, and have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, ensuring zero animal-derived TSE/BSE risk. Additionally, these products are validated by multiple internationally recognized agencies such as SGS and NF, delivering fully verified and reliable filtration solutions for the entire biopharmaceutical process, sourced from trusted China suppliers

    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,
    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: 0.075m²   02: 0.14m²   04: 0.25m²   05: 0.34m²   10: 0.68m²
    * 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 vs. Flow Rate at 20 °C (L/min)
    Frequently Asked Questions
    What are the primary applications for this PES capsule filter?
    Typical applications include the prefiltration of cell culture media and buffer filtration in biopharmaceutical production.
    What materials are used in the construction of the filter?
    The filter membrane is made of Hydrophilic Polyethersulfone (PES), the inner/outer cage and capsule housing are made of Polypropylene (PP), and the capsule vent O-ring is Silicone Rubber.
    What is the maximum operating temperature and pressure?
    The maximum operating temperature is 80℃. The maximum differential pressure limits are 0.55MPa at 25℃ and 0.1MPa at 80℃.
    How can the Challenge Pore® PES capsule filter be sterilized?
    It can be sterilized using high-temperature steam at 121 °C for 30 minutes (up to 5 cycles) or through gamma irradiation at a range of 25–40 kGy.
    Does the capsule filter meet biosafety standards?
    Yes, the filter meets biocompatibility requirements. It is compliant with USP <87> Non-cytotoxic standards, meets USP <88> Class VI plastic biocompatibility requirements, and has endotoxin levels <0.25 EU/mL.