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China Challenge Filair® PTFE Hydrophobic Sterile Filters - High Retention & Throughput from Trusted Suppliers & Factory

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The Challenge IM Capsule Filters represent a comprehensive solution for biopharmaceutical processes in China, covering five essential 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 effectively meet all process requirements from cell culture clarification to final product sterilization. Designed for flexibility, they support high-temperature steam sterilization and gamma irradiation, making them compatible with a variety of commonly used biopharmaceutical solvents.

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All molded parts and sealing components are free of colorants, adhering to Class VI and ISO 10993 biocompatibility standards to minimize leachables and extractables while ensuring hygienic processing. Each filter undergoes rigorous dual integrity testing during production, utilizing two independent test methods for release, guaranteeing a 100% factory pass rate. Our commitment to quality is reflected in compliance with ISO 9001 quality management and GMP standards, alongside successful certifications from USP endotoxin, USP / biocompatibility, and USP extractables tests, eliminating any animal-derived TSE/BSE risks.

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As one of the leading suppliers in China, we take pride in our products, validated by multiple internationally recognized agencies such as SGS and NF. Trust Challenge IM Capsule Filters for fully verified and reliable filtration solutions throughout your entire biopharmaceutical process.

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    Features

    • Natural hydrophobicity
    • High retention rate
    • High throughput with low pressure drop
    • Reliable bacteria and particle retention

    Typical Applications

    • Vents for Fermenters, Storage Tanks, etc.
    • Sterile Filtration for Compressed Air, O₂, N₂, etc.

    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

    • Disc Filter: D50: 20 cm²
    • Capsule Filter:
      • 01: 0.075m²
      • 02: 0.14m²
      • 04: 0.25m²
      • 05: 0.34m²
      • 10: 0.68 m²

    Sterilization

    Challenge Filair® PTFE filter capable of up to 50 cycles of high-temperature steam sterilization.

    Material Construction

    Filter Membrane Hydrophobic Polytetrafluoroethylene (PTFE)
    Inner Cage, Outer Cage Polypropylene (PP)
    Capsule Housing Polypropylene (PP)
    Capsule Vent O-Ring Silicone Rubber
    Filtration Accuracy 0.2μm

    0.2μm Gas Capsule Filter Flow Rate

    0.2μm Gas Capsule Filter Flow Rate Diagram
    Differential Pressure Flow Rate at 20 °C: (L/min)

    Frequently Asked Questions (FAQ)

    Q: What is the filtration accuracy of this gas capsule filter?

    The filtration accuracy of this gas capsule filter is 0.2μm.

    Q: What materials are used in the construction of the filter?

    The filter membrane is made of Hydrophobic Polytetrafluoroethylene (PTFE), the inner cage, outer cage, and capsule housing are Polypropylene (PP), and the capsule vent O-ring is Silicone Rubber.

    Q: What are the maximum operating conditions for temperature and pressure?

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

    Q: How many sterilization cycles can this filter withstand?

    The Challenge Filair® PTFE filter is capable of undergoing up to 50 cycles of high-temperature steam sterilization.

    Q: Does the filter meet international biosafety standards?

    Yes, it is compliant with USP <87> Non-cytotoxic standards and meets USP <88> Class VI plastic biocompatibility requirements with endotoxin levels under 0.25 EU/mL.

    Q: What dimensions are available for the Disc and Capsule filters?

    The Disc Filter features a D50 size of 20 cm². The Capsule Filter is available in filtration areas of 0.075m² (01), 0.14m² (02), 0.25m² (04), 0.34m² (05), and 0.68 m² (10).