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China Challenge Filair® PTFE Sterile Filters - High Throughput & Retention | Suppliers & Factory Direct

The Challenge IM Capsule Filters are essential solutions designed for the biopharmaceutical industry, covering five key 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 meet comprehensive process requirements from cell culture clarification to final product sterilization. Our filters support high-temperature steam sterilization and gamma irradiation and are compatible with a wide variety of biopharmaceutical solvents commonly used in the market, Manufactured with precision in our Factory, all molded parts and sealing components are free from colorants, ensuring compliance with Class VI and ISO 10993 biocompatibility standards to minimize leachables and extractables for hygienic processing. Dual integrity testing during production guarantees that each product undergoes two independent test methods for release, ensuring a 100% factory pass rate, As a leading China supplier, our filters comply with ISO 9001 quality management and GMP standards, successfully passing rigorous testing including USP endotoxin, USP / biocompatibility, and USP extractables tests, with no risk of animal-derived TSE/BSE. All of our products are validated by multiple internationally recognized agencies like SGS and NF, delivering verified and reliable filtration solutions for the entire biopharmaceutical process

    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 Specifications

    Frequently Asked Questions (FAQ)

    Q: What makes the PTFE filter membrane naturally hydrophobic?
    Polytetrafluoroethylene (PTFE) possesses inherent hydrophobic properties due to its chemical structure of carbon and fluorine bonds, which resist water and moisture, making it ideal for gas venting and sterile air filtration.
    Q: What are the typical applications for these PTFE filters?
    They are commonly used as sterile vents for fermenters and storage tanks, as well as for the sterile filtration of compressed gases such as Air, Oxygen (O₂), and Nitrogen (N₂).
    Q: What is the maximum operating temperature and pressure limit?
    The maximum operating temperature is 80℃. The maximum differential pressure is 0.55MPa at 25℃ and 0.1MPa at 80℃.
    Q: Are these filters compliant with biocompatibility and biosafety standards?
    Yes, they are highly biocompatible, meeting USP <87> Non-cytotoxic standards and USP <88> Class VI plastic biocompatibility requirements, with an endotoxin limit of less than 0.25 EU/mL.
    Q: Can the Filair® PTFE filter withstand steam sterilization?
    Yes, the filter is designed for durability and can withstand up to 50 cycles of high-temperature steam sterilization under challenging conditions.
    Q: What materials are used in the construction of the capsule filter?
    The filter membrane is made of Hydrophobic PTFE, the inner/outer cages and capsule housing are constructed from durable Polypropylene (PP), and the vent O-ring is made of Silicone Rubber.