zh-cn
  • sns01-1
  • sns04-1
  • sns02-1
Leave Your Message

High-Quality Challenge Filair® PTFE Hydrophobic Sterile Filters from China Suppliers and Factory for Biopharmaceuticals

Introducing the Challenge IM Capsule Filters, the ideal solution for the biopharmaceutical industry, available through trusted China suppliers. 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 cater to the entire process, from cell culture clarification to final product sterilization, Manufactured by our expert factory, these filters support high-temperature steam sterilization and gamma irradiation, making them compatible with a wide array of commonly used biopharmaceutical solvents. Each molded part and sealing component is free of colorants, ensuring compliance with Class VI and ISO 10993 biocompatibility standards. This minimizes leachables and extractables, safeguarding hygienic processing, To guarantee quality, every product undergoes rigorous dual integrity testing during production, enforcing two independent test methods before release, which ensures a 100% factory pass rate. Our filters comply with ISO 9001 quality management and GMP standards and have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, with no risk of animal-derived TSE/BSE, Validated by multiple globally recognized agencies including SGS and NF, our Challenge IM Capsule Filters provide fully verified and reliable filtration solutions for your entire biopharmaceutical process, making them an essential choice for manufacturers seeking quality solutions from China suppliers

    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: 0.075m 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.
    Filair PTFE Filter Membrane and Capsule Filter Dimensions

    Frequently Asked Questions (FAQ)

    Q1: What are the key features of the Filair® PTFE filter?

    The filter features natural hydrophobicity, a high retention rate, high throughput with low pressure drop, and reliable bacteria and particle retention.

    Q2: What typical applications is this PTFE filter designed for?

    It is typically used as vents for fermenters and storage tanks, as well as for sterile filtration of compressed air, oxygen (O₂), nitrogen (N₂), and other gases.

    Q3: 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℃.

    Q4: What materials are used in the construction of this filter?

    The filter membrane is made of Hydrophobic Polytetrafluoroethylene (PTFE). The inner cage, outer cage, and capsule housing are made of Polypropylene (PP), while the capsule vent O-ring is made of Silicone Rubber. The filtration accuracy is 0.2μm.

    Q5: Does the filter meet biosafety and biocompatibility standards?

    Yes. It has an endotoxin level of <0.25 EU/mL. It is compliant with USP <87> Non-cytotoxic standards and meets USP <88> Class VI plastic biocompatibility requirements.

    Q6: How many high-temperature steam sterilization cycles can the filter withstand?

    The Filair® PTFE filter is challenged to withstand up to 50 cycles of high-temperature steam sterilization.