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China TFF System by Suppliers - Fully Automated Tangential Flow Filtration Factory for Efficient Bioprocessing

The single-use, fully automated tangential flow filtration (TFF) system is designed with GMP-compliant fluid contact materials, providing efficient and flexible filtration solutions tailored to meet production demands from clinical development to commercial manufacturing. This advanced system facilitates intuitive operation and seamless scalability across various process scales, enabling users to significantly reduce production time and costs. Widely utilized by suppliers and factories in China, this system is essential for the manufacturing of monoclonal antibodies, antibody-drug conjugates (ADCs), gene therapies, viral products, mRNA vaccines, and plasmid DNA. It effectively supports critical processes such as concentration, purification, and continuous buffer exchange, making it an invaluable asset for any production facility
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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 single-use design simplify cleaning validation?
    The single-use design concept eliminates the need for complex cleaning processes between batches, directly addressing cross-contamination risks and significantly simplifying the cleaning validation workflow.
    What level of automation does this TFF system offer?
    The system features a fully automated process covering everything from automatic feeding to online integrity testing. This minimizes manual intervention and ensures highly reliable, intelligent tangential flow operations.
    Does the system support PUPSIT compliance?
    Yes, the system is designed to support PUPSIT (Pre-Use Post-Sterilization Integrity Testing), ensuring full compliance with MEA and other relevant global regulatory standards.
    What types of filtration membranes can be used with this system?
    It offers flexible membrane compatibility, supporting both standard cassette membranes and hollow fibers to accommodate different process development and production setups.
    Is validation documentation provided for FDA compliance?
    Yes, the system is fully compliant with FDA 21 CFR Part 11 regulations, and complete validation documentation is provided to support your regulatory submission and auditing processes.