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China Suppliers Factory: Automated Tangential Flow Filtration (TFF) System for Biopharmaceutical Production

The single-use, fully automated tangential flow filtration (TFF) system is designed with GMP-compliant fluid contact materials, providing efficient and flexible filtration solutions for various production needs, from clinical development to commercial manufacturing. This advanced system is intuitive to operate and easily scalable across different process scales, enabling users in China to significantly reduce production time and costs. As a leading choice among suppliers and manufacturers, this system is widely utilized in the production 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 essential asset for any factory focused on high-quality biopharmaceutical production
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    Product Detail

    Features

    Single-use Design

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

    High Automation

    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.

    PUPSIT Support

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

    Compact Layout

    Compact tubing layout ensures minimal hold-up volume.

    Membrane Compatibility

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

    Adaptable Setup

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

    FDA Compliance

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

    Frequently Asked Questions

    How does the single-use design benefit cleaning validation?

    The single-use design concept eliminates the need for complex cleaning validation protocols, saving time, reducing cross-contamination risks, and streamlining operational workflows.

    What level of automation does this TFF system offer?

    The system features a high level of automation that covers the entire TFF process, from automatic feed setup to online integrity testing, minimizing manual intervention and ensuring intelligent operation.

    Does this system support PUPSIT?

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

    What type of membranes can be used with this TFF system?

    This system offers flexible membrane compatibility, allowing it to support both cassette membranes and hollow fibers depending on your process requirements.

    Is the system compliant with regulatory standards?

    Yes, it is compliant with FDA 21 CFR Part 11, and we provide complete validation documentation to support your compliance needs.