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Challenge Filair® PTFE Hydrophobic Sterile Filter with High Retention and High Throughput

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Challenge Pore® PES Hydrophilic Filter with High Mycoplasma Retention

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Challenge Pore® PES Low-Protein-Binding Hydrophilic Sterile Filter

Challenge Pore® PES Low-Protein-Binding Hydrophilic Sterile Filter
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Challenge Dream+ Tangential Flow Filtration (TFF) System | China Suppliers & Factory for GMP-Compliant Filtration Solutions

Introducing our state-of-the-art single-use, fully automated tangential flow filtration (TFF) system, designed with GMP-compliant fluid contact materials. This cutting-edge filtration solution is ideal for suppliers and factories in China, facilitating efficient and flexible production processes from clinical development to commercial manufacturing. Our system boasts intuitive operation and seamless scalability, allowing users to significantly minimize production time and costs. Perfectly suited for the manufacturing of monoclonal antibodies, ADCs, gene therapies, viral products, mRNA vaccines, and plasmid DNA, it supports key processes such as concentration, purification, and continuous buffer exchange. Choose our advanced TFF system to elevate your production capabilities today
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    Product Detail

    Features

    Single-use design concept easily addresses the challenges of cleaning validation;

    High level of automation from automatic feed to online integrity testing, the entire TFF process is fully automated, minimizing risks from manual intervention and achieving truly intelligent tangential flow operation;

    Supports PUPSIT (Pre-Use Post-Sterilization Integrity Testing), compliant with MEA and other relevant regulatory requirements;

    Compact tubing layout ensures minimal hold-up volume;

    Flexible membrane compatibility, supports both cassette membranes and hollow fibers;

    Adaptable to different setups, flexibly integrate with various single-use bags or tanks based on user requirements;

    Compliant with FDA 21 CFR Part 11, complete validation documentation is provided.

    Frequently Asked Questions

    How does the system simplify cleaning validation?

    The system features a single-use design concept that easily addresses the challenges associated with cleaning validation.

    What level of automation does this TFF process offer?

    It features a high level of automation from automatic feed to online integrity testing. The entire TFF process is fully automated, minimizing risks from manual intervention and achieving truly intelligent tangential flow operation.

    Does the system support PUPSIT?

    Yes, it supports PUPSIT (Pre-Use Post-Sterilization Integrity Testing) and is compliant with MEA and other relevant regulatory requirements.

    What types of membranes are compatible with this system?

    The system offers flexible membrane compatibility, supporting both cassette membranes and hollow fibers.

    Can the system be integrated with different bags or tanks?

    Yes, it is adaptable to different setups and can flexibly integrate with various single-use bags or tanks based on user requirements.

    Is the system compliant with FDA 21 CFR Part 11?

    Yes, the system is compliant with FDA 21 CFR Part 11, and complete validation documentation is provided.