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

The Challenge IM Capsule Filters are an essential solution for biopharmaceutical processing, provided by leading China suppliers known for their quality manufacturing practices. Our filters encompass five key series: clarification, pre-filtration & sterilizing-grade, sterile, mycoplasma removal, and gas filtration, offering particle retention from 0.1 to 30 µm. These filters meet comprehensive process requirements, ensuring optimal cell culture clarification and final product sterilization, Manufactured in a certified factory, these filters are capable of high-temperature steam sterilization and gamma irradiation, compatible with a wide range of commonly used biopharmaceutical solvents. To ensure the highest hygiene standards, all molded parts and sealing components are free of colorants and meet Class VI and ISO 10993 biocompatibility standards, minimizing leachables and extractables, Our rigorous quality assurance process includes dual integrity testing during production, requiring two independent test methods for product release to guarantee a 100% factory pass rate. Aligned with ISO 9001 quality management and GMP standards, our filters have successfully passed USP endotoxin testing, USP / biocompatibility tests, and USP extractables assessments, presenting no animal-derived TSE/BSE risk, Trusted by professionals, our products are validated by multiple internationally recognized agencies such as SGS and NF, providing fully verified and reliable filtration solutions tailored to the entire biopharmaceutical process

    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

    Parameter Specification
    Maximum operating temperature 80℃
    Maximum differential pressure 0.55MPa/25℃, 0.1MPa/80℃

    Biosafety

    Test Item Standard / Compliance
    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

    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 / 30μm

    Frequently Asked Questions

    Q1: What are the main features of the Challenge Pore® PP capsule filter?

    A: It features multiple layers of polypropylene membranes with varying pore sizes, scientifically combined to deliver high retention, high throughput, and outstanding fouling capacity.

    Q2: What materials are used in the construction of this filter?

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

    Q3: Does the filter meet international biosafety standards?

    A: Yes, it is highly compliant. The endotoxin level is <0.25 EU/mL, it is compliant with USP <87> Non-cytotoxic standards, and it meets USP <88> Class VI plastic biocompatibility requirements.

    Q4: What are the limits for operating temperature and differential pressure?

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

    Q5: How many times can the capsule filter be steam sterilized?

    A: The Challenge Pore® PP capsule filter is designed to withstand up to 25 cycles of high-temperature steam sterilization.

    Q6: What filtration accuracies and effective filtration areas are available?

    A: 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 (filtration area) include 0.04㎡, 0.08㎡, 0.15㎡, 0.2㎡, and 0.4㎡.