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High-Performance Clarification Filters from China Suppliers | Factory-Validated Challenge Pore® PP Filters

The Challenge IM Capsule Filters are essential filtration solutions designed for the biopharmaceutical industry, offered by leading China suppliers. Our product line encompasses five key series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration, featuring particle retention capabilities from 0.1 to 30 µm. These filters are engineered to meet comprehensive process requirements, from cell culture clarification to final product sterilization, Manufactured in a state-of-the-art factory, the filters can endure high-temperature steam sterilization and gamma irradiation, and they are compatible with a wide array of commonly used biopharmaceutical solvents. All molded parts and sealing components are devoid of colorants, adhering to Class VI and ISO 10993 biocompatibility standards, which minimizes leachables and extractables, ensuring hygienic processing, To guarantee quality, each filter undergoes dual integrity testing during production, requiring two independent test methods for product release, achieving a 100% factory pass rate. Our filters are compliant with ISO 9001 quality management and GMP standards, and they have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, with no risk of animal-derived TSE/BSE, Validated by multiple internationally recognized agencies, including SGS and NF, our Challenge IM Capsule Filters provide fully verified and reliable filtration solutions for the entire biopharmaceutical process, made available by trusted China suppliers

    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℃

    Sterilization

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

    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㎡

    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

    What materials are used to construct the capsule filter?

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

    What are the typical applications for this PP capsule filter?

    It is typically used for 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.

    What are the maximum operating temperature and pressure limits?

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

    Does the filter meet biosafety and biocompatibility standards?

    Yes. The filter 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.

    How many sterilization cycles can the filter withstand?

    The Challenge Pore® PP capsule filter is capable of withstanding up to 25 cycles of high-temperature steam sterilization.

    What filtration accuracies and sizes 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, and 30μm). Available filter dimensions include 0.04㎡ (01), 0.08㎡ (02), 0.15㎡ (04), 0.2㎡ (05), and 0.4㎡ (10).