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

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The Challenge IM Capsule Filters are designed to meet the diverse needs of the biopharmaceutical industry in China. Our filters cover five essential series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration, featuring particle retention from 0.1 to 30 μm. This comprehensive range ensures that all process requirements, from cell culture clarification to final product sterilization, are efficiently met. Manufactured in our state-of-the-art factory, our filters support high-temperature steam sterilization and gamma irradiation while being compatible with a broad spectrum of commonly used biopharmaceutical solvents.

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Each component, including all molded parts and sealing elements, is free from colorants and adheres to Class VI and ISO 10993 biocompatibility standards, significantly reducing leachables and extractables for hygienic processing. Additionally, every filter undergoes dual integrity testing during production, requiring two independent test methods to ensure a 100% factory pass rate. Our filters align with ISO 9001 quality management and GMP standards and have successfully passed USP endotoxin, USP / biocompatibility, and USP extractables tests, eliminating any TSE/BSE risk. Recognized by multiple international agencies such as SGS and NF, our filters provide reliable filtration solutions for the entire biopharmaceutical process, making us the preferred choice among suppliers in China.

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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

    Max Operating Temp. 80℃
    Max Differential Pressure (25℃) 0.55 MPa
    Max Differential Pressure (80℃) 0.1 MPa

    Biosafety

    Endotoxin <0.25 EU/mL
    Biocompatibility
    • Compliant with USP <87> Non-cytotoxic
    • Meets USP <88> Class VI plastic biocompatibility requirements

    Filter Dimensions

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

    Sterilization

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

    Material Construction

    Component Material / Specification
    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 / 30 μm

    Frequently Asked Questions

    What materials are used to construct the Challenge Pore® PP capsule filters?
    The filter membrane, inner cage, outer cage, and capsule housing are all constructed from high-quality Polypropylene (PP). The capsule vent O-ring is made of Silicone Rubber.
    What are the typical applications for these capsule filters?
    They are ideal for the prefiltration of cell culture media, clarification of fermentation broth or cell culture fluids, prefiltration of serum and blood products, and the 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 is 0.55 MPa at 25℃ and 0.1 MPa at 80℃.
    Do these capsule filters comply with biosafety standards?
    Yes, they meet strict biosafety requirements. The endotoxin level is under 0.25 EU/mL. They are compliant with USP <87> Non-cytotoxic standards and meet the USP <88> Class VI plastic biocompatibility requirements.
    How many sterilization cycles can this capsule filter handle?
    The Challenge Pore® PP capsule filter is designed to withstand up to 25 cycles of high-temperature steam sterilization.
    What filtration accuracies and sizes are available?
    Filtration accuracies range from 0.2μm to 30μm (including 0.2, 0.5, 0.65, 1.0, 3.0, 5.0, 10, 20, and 30μm). Available filtration areas (dimensions) range from 0.04㎡ (Model 01) up to 0.4㎡ (Model 10).