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High-Performance Challenge Pore® PP Filters from China Suppliers - Reliable Biopharmaceutical Filtration Factory

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The Challenge IM Capsule Filters are manufactured by leading suppliers in China, designed to meet the comprehensive filtration needs of the biopharmaceutical industry. Our filters cover five essential series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration, offering particle retention from 0.1 to 30 µm. These filters fulfill critical requirements from cell culture clarification to final product sterilization. Engineered to support high-temperature steam sterilization and gamma irradiation, they are compatible with a wide array of biopharmaceutical solvents. All molded parts and sealing components are colorant-free and adhere to Class VI and ISO 10993 biocompatibility standards, significantly minimizing leachables and extractables for hygienic processing. Each filter undergoes rigorous dual integrity testing during production, ensuring a 100% factory pass rate with two independent test methods required for product release. Our filters comply with ISO 9001 quality management and GMP standards and have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, posing no TSE/BSE risk from animal-derived materials. All products are validated by multiple internationally recognized agencies, including SGS and NF, delivering verified and reliable filtration solutions for every stage of the biopharmaceutical process.

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    Features

    • Constructed with multiple layers of polypropylene membranes of varying pore sizes, scientifically combined to provide high retention, high throughput, and excellent fouling capacity.

    Typical Applications

    • Prefiltration of cell culture media
    • Clarification of fermentation broth or cell culture fluids
    • Prefiltration of serum and blood products
    • Prefiltration of colloidal or viscous liquids

    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

    01: 0.04㎡
    02: 0.08㎡
    04: 0.15㎡
    05: 0.2㎡
    10: 0.4㎡

    Sterilization

    • Challenge Pore® PP capsule filter capable of up to 25 cycles of high-temperature steam sterilization

    Material Construction

    Filter Membrane Polypropylene (PP)
    Inner Cage, Outer Cage Polypropylene (PP)
    Capsule Housing Polypropylene (PP)
    Capsule Vent O-Ring Silicone Rubber
    Filtration Accuracy 0.2/0.5/0.65/1.0/3.0/5.0/10/20/30μm

    Frequently Asked Questions

    Q: What is the material construction of the filter membrane and housing?
    The filter membrane, inner cage, outer cage, and capsule housing are all constructed from Polypropylene (PP). The capsule vent O-ring is made of Silicone Rubber.
    Q: What are the typical applications for this PP capsule filter?
    Typical applications include the prefiltration of cell culture media, clarification of fermentation broth or cell culture fluids, prefiltration of serum and blood products, and prefiltration of colloidal or viscous liquids.
    Q: What are the maximum operating temperature and pressure limits?
    The maximum operating temperature is 80℃. The maximum differential pressure limits are 0.55MPa at 25℃ and 0.1MPa at 80℃.
    Q: Does this filter meet biosafety standards?
    Yes, it is compliant with USP <87> Non-cytotoxic standards and meets the USP <88> Class VI plastic biocompatibility requirements. Additionally, the endotoxin level is <0.25 EU/mL.
    Q: How many sterilization cycles can this capsule filter withstand?
    The Challenge Pore® PP capsule filter is capable of withstanding up to 25 cycles of high-temperature steam sterilization.
    Q: What filtration accuracy options and dimensions are available?
    Filtration accuracies range from 0.2 to 30μm (including 0.2/0.5/0.65/1.0/3.0/5.0/10/20/30μm). Available filter dimensions include effective filtration areas of 0.04㎡ (01), 0.08㎡ (02), 0.15㎡ (04), 0.2㎡ (05), and 0.4㎡ (10).