Single-Use Assemblies

Our full range of stainless steel connectors delivers reliable and proven aseptic performance

Whether you are looking to introduce single-use manufacturing components into your current process or investigating how you can implement a single-use process train, Mobius® 2D and 3D single-use assemblies and solutions can help you meet your changing manufacturing requirements.

Mobius® 2D and 3D bag assemblies

Our Mobius® 2D and 3D assemblies are key components for efficient and scalable bioprocessing fluid management solutions, from media and buffer preparation to final fill applications. With a full spectrum of solutions to choose from, at varying levels of certification, you get greater flexibility, mobility, and support for your single-use technologies. Our assemblies and solutions are designed to reduce operator error and process risks while improving efficiency. With our proprietary EZ Fold technique, filling and deployment of our Mobius® 3D bag assemblies are made easy for operators.

Solutions include:

  • 2D assemblies and hardware
  • Drum assemblies and hardware
  • Collapsible bin assemblies and hardware
  • Stainless steel bin assemblies and hardware
  • Transport bin assemblies and hardware
  • Bags for mixers and bioreactors



Mobius® MyWay – Options to Suit Your Supply Needs

Mobius® MyWay is a comprehensive three-tiered program designed to promote a balance of single-use lead times with design flexibility, while enhancing supply security. Mobius® MyWay allows you to have the flexibility of ordering standard and configurable “fit for purpose” assemblies while still receiving the benefits of documentation support and extractable data at reduced lead times. Our unique approach reduces consumable management burden and cost, enhances supply transparency, and improves security.

MOBIUS® STOCK

Mobius® Stock: Off-the-shelf standard assemblies

    MOBIUS® SELECT

    Mobius<sup>®</sup> Select

      MOBIUS® CHOICE

      Mobius<sup>®</sup> Choice

        Off-the-Shelf Standard Assemblies

        Configure-to-Order Assemblies, Using a Library of Prequalified Components

        Highly Customized Solutions

        Mobius® assemblies are available in several levels of certification. Certification of an assembly is based on the qualification of the components in the assembly, the level of leak testing performed during manufacturing, and the testing performed on the assembly lot after manufacturing. The certification level also impacts the shelf life and sterility claims that are made for the assembly.

        Helium Integrity Manufacturing Release Test for Increased Integrity Assurance

        Mobius® single-use assemblies* can also be tested with a Helium Integrity Manufacturing Release Test. Our Helium integrity test (HIT) is validated to detect defects as small as 2 µm, and is designed to test the entire single-use assembly, including tubing and connection points. Incorporating HIT into your integrity assurance strategy reduces the risk of leaks or microbial ingress in your manufacturing process.

        * Mobius® assemblies for Helium Integrity Test is subject to the HIT design space rules. Please find the details in the HIT Data Sheet.


        Mobius® bag assemblies are made with PureFlex™ and PureFlex™ Plus films, providing the flexibility and robustness to support your single-use technologies.

        Single-use film technology

        Our PureFlex™ single-use process container films are used for the construction of Mobius® single-use 2D and 3D bag assemblies. Both PureFlex™ and PureFlex™ Plus films consist of a single fluid contact layer with a low extractable profile, chemically resistant materials, and zero animal-derived components, offering the flexibility and robustness you need throughout your single-use manufacturing processes.

        Emprove® Program and dossiers

        The Emprove® Program supports your risk assessment and assists in developing more robust processes. It provides comprehensive and thorough documentation of our filters and single-use components, as well as pharma raw and starting materials. It not only covers the latest regulatory requirements, but also anticipates industry expectations not yet covered by regulation. The Emprove® Program is organized in three different types of dossiers. Every dossier supports you throughout different stages of your operations: material qualification, risk assessment, and process optimization.

        Quality control and assurance to support your bioprocess risk mitigation

        With a global network of sales development specialists and engineers we can support you with system demonstration, design and implementation, at-scale process simulation, and feasibility studies, as well as validation studies and documentation, supported by BioReliance® validation services.
        We take a holistic risk mitigation approach covering:

        • Component and assembly qualification
        • Bag and assembly manufacturing process
        • Integrity testing
        • Packaging, irradiation, and shipping