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

Introducing our cutting-edge single-use, fully automated tangential flow filtration (TFF) system, designed with GMP-compliant fluid contact materials. This highly efficient filtration solution is perfect for China-based suppliers and factories, catering to a wide range of production needs from clinical development to commercial manufacturing. Our intuitive operation and seamless scalability allow for easy adaptation across varying process scales, helping users in China significantly reduce both production time and costs. This versatile system is widely utilized in the manufacturing of monoclonal antibodies, ADCs, gene therapies, viral products, mRNA vaccines, and plasmid DNA, making it ideal for processes such as concentration, purification, and continuous buffer exchange. Optimize your production with our advanced TFF system today!

    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

    Q1: How does the single-use design address cleaning validation challenges?

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

    Q2: What processes are automated in this TFF system?

    The system features a high level of automation that covers the entire TFF process, from automatic feeding to online integrity testing. This minimizes manual intervention and ensures highly intelligent, repeatable operations.

    Q3: Does the system comply with regulatory standards like PUPSIT?

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

    Q4: How does the system minimize product hold-up volume?

    The system is engineered with a compact tubing layout, which ensures minimal hold-up volume and maximizes the recovery of valuable products.

    Q5: What types of membranes can be used with this system?

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

    Q6: Is this TFF system compliant with FDA 21 CFR Part 11?

    Yes, it is fully compliant with FDA 21 CFR Part 11 regulations, and complete validation documentation is provided to support compliance audits.