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

Introducing the Challenge IM Capsule Filters, designed to meet the diverse filtration needs of the biopharmaceutical industry. Our comprehensive range includes five key series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration, with particle retention capabilities from 0.1 to 30 µm. These filters are essential for the entire process, from cell culture clarification to final product sterilization, Manufactured in our state-of-the-art factory in China, the Challenge IM Capsule Filters are engineered to support high-temperature steam sterilization and gamma irradiation. They are compatible with a wide array of commonly used biopharmaceutical solvents, ensuring versatility and reliability in your processes. All molded parts and sealing components are devoid of colorants and adhere to Class VI and ISO 10993 biocompatibility standards, significantly reducing leachables and extractables for hygienic processing, To guarantee product integrity, each filter undergoes rigorous dual integrity testing during production, requiring two independent test methods for release, achieving a 100% factory pass rate. Our filters comply with ISO 9001 quality management and GMP standards and have successfully passed crucial testing such as USP endotoxin, USP / biocompatibility, and USP extractables tests, ensuring no animal-derived TSE/BSE risk, Collaborating with recognized agencies like SGS and NF, we provide fully verified and reliable filtration solutions for the entire biopharmaceutical process. Trust the quality and performance of Challenge IM Capsule Filters, sourced from leading suppliers in China, for your filtration needs

    Features

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

    Typical Application

    • 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℃

    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

    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.
    Filair PTFE Filter Dimension and Structure Diagram

    Frequently Asked Questions

    Q What are the main features of the Filair® PTFE filter?
    The filter features natural hydrophobicity, a high retention rate, high throughput with low pressure drop, and reliable retention of bacteria and particles.
    Q What materials are used in the construction of this filter?
    It is constructed with a Hydrophobic Polytetrafluoroethylene (PTFE) membrane, Polypropylene (PP) for the inner cage, outer cage, and capsule housing, and Silicone Rubber for the capsule vent O-ring.
    Q What are the maximum 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℃.
    Q Does the filter meet biosafety and biocompatibility standards?
    Yes, it has endotoxin levels under 0.25 EU/mL, is compliant with USP <87> Non-cytotoxic standards, and meets USP <88> Class VI plastic biocompatibility requirements.
    Q What are the available dimensions for the disc and capsule filters?
    The Disc Filter is available in D50 (20cm²). The Capsule Filter is available in sizes 01 (0.075m²), 02 (0.14m²), 04 (0.25m²), 05 (0.34m²), and 10 (0.68m²).
    Q Can this filter withstand steam sterilization?
    Yes, the Filair® PTFE filter can withstand up to 50 cycles of high-temperature steam sterilization.