MilliporeSigma
HomeProductsPharma & Biopharma ManufacturingFluid ManagementSingle-Use Assemblies

Single-Use Assemblies

Slide 1 of 4
  • Mobius® 3D Bag Assembly in 3D Large Liquid Transport Bin
  • Single-Use Mobius® Essential simple bioprocess bag and tubing assemblies are made with our industry proven films

    Mobius® Essential assemblies can be easily integrated into your workflow with 2D and 3D bioprocess bag assembly sizes ranging from 1 L - 200 L and three bioprocess tubing designs.

  • Ultimus® film technology provides enhanced bioprocess bag strength, improved durability and leak resistance through a novel strength layer reinforced by woven nylon

    Ultimus® film is now available in Mobius® 3D assemblies.

  • Our Ultimus® film technology provides enhanced bioprocess bag strength, improved durability and leak resistance through a novel strength layer reinforced by woven nylon

    Our Ultimus® film was designed to meet the needs of more challenging single-use applications such as large-volume liquid processing.

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 provide 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.

We're committed to developing high-performance products that continually evolve with your needs. To ensure you stay ahead in your manufacturing, we provide standard ready-to-ship assemblies that are off-the-shelf for immediate process needs.

Solutions include:

Order Now

Scalable Single-use Assemblies to Meet Your Bioprocess Needs

Mobius® Essential Assemblies are standard, off-the-shelf, simple bioprocess bag and tubing assemblies. These plug-and-play assemblies are made of our proven PureFlex™ film and are available in both 2D bags (1–50 L), 3D bags (100–200 L), as well as bioprocess tubing assemblies.

These standard assemblies are easily integrated into your current processes providing you with a straight path for scale-up to our Mobius® MyWay assemblies with PureFlex™ film.

  • Eliminate design and manufacturing lead time
  • 1 L - 200 L sizes that can easily scale up to premium assemblies under Mobius® MyWay program
  • Ready-to-download Emprove® Dossier with comprehensive product and regulatory information

Simply select your bag and tubing assemblies, click to cart today.

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 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 the Helium Integrity Test 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 design space rules. Please find the details in the Helium Test Data Sheet.

        Slide 1 of 2
        • Our Ultimus® film technology provides enhanced bioprocess bag strength, improved durability and leak resistance through a novel strength layer reinforced by woven nylon

          Ultimus® film has a Cutting-edge Design with Woven Nylon.

        • 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 Ultimus® film was designed for superior robustness and durability in large-volume processing through a proprietary woven nylon structure. The fluid contact layer is animal origin-free, with low extractable, and supports healthy cell growth as it does not contain Irgafos® 168. 

        Our PureFlex™ 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.

        Have a question about Ultimus® film? Contact our technical experts here. 

        Contact Our Technical Expert

        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. 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

        Related Product Resources

        Product Specification
        Brochure: Single-use Fluid Management: 2D and 3D Assemblies, Filtration, Storage, and Transportation Solutions
        Data Sheet: Mobius® 2D Freeze Assembly
        Spec Sheet: Mobius® Essential Assembly

        Extractables and Leachables
        White Paper: The Role of BPOG Extractables Data in the Effective Adoption of Single-use Systems
        White Paper: PureFlex™ and PureFlex™ Plus Disposable Process Container Films Extractables Evaluation

         

        Single-Use Bioprocessing Film
        Spec Sheet: Ultimus® Film
        White Paper: Single-Use Upstream Processing: Ultimus® Film Delivers Comparable Cell Growth Performance To Glass
        Infographic: Prevent Costly Bag Leaks in Single-Use Manufacturing
        Technical Brief: Demonstrated Strength and Durability of Ultimus® Film
        Spec Sheet: PureFlex™ Single-Use Process Container Films

        Related Product Categories
        Single-Use Mixers
        Our complete range of Mobius® single-use mixing solutions can meet your needs for mixing pharmaceutical ingredients from intermediate to final drug products, as well as preparation of process solutions such as buffers and media.
        Sterile Sampling
        Flexible. Safe. Contamination free. Closed system ensures aseptic processing conditions. With configurable holders and single-use sampling assemblies, NovaSeptum® GO sterile sampling system provides representative samples for QC labs testing for bioburden, endotoxin, process sterility, and monitoring pH and osmolality.
        Fluid Transport & Storage
        For single-use manufacturing, Mobius® liquid storage systems offer PE drums, stainless steel bins, collapsible bins, and container carts that deliver efficient, scalable, reliable fluid management solutions to your production floor.
        Connection/Disconnection for Bioprocessing
        Our single-use or stainless steel-based fluid transfer systems feature Lynx sterile connectors and various tubing types to provide sterile fluid transfer between steps in your aseptic bioprocess.
        Final Sterile Filtration & Filling
        Pre-sterilized, single-use filling systems offer speed and flexibility for critical final filtration and final fill operations. Learn how advances in aseptic filtration simplify PUPSIT and enable optimized sterile fill finish operations.
        Buffers & pH Adjusters
        Our broad portfolio of buffer materials manufactured according to GMP guidelines includes excipients specifically for drug formulation and manufacturing, including high-risk applications. Whether your product is a small or large molecule drug, we offer high-quality buffers and pH adjusters with regulatory support.
        Bioprocessing Liquid Cell Culture Media & Buffers
        We offer the industry’s highest quality sterile liquid capabilities, supplying ready-to-use cell culture media, buffers, CIP and SIP products from GMP facilities worldwide to optimize your biopharma production.
        Related Applications
        Pharmaceutical & Biopharmaceutical Manufacturing
        Find application data for pharma and biopharma manufacturing. Explore next gen bioprocessing and our workflow for drug discovery, development, and commercialization.
        Blood Plasma Fractionation
        Consistent, reliable performance is key to blood plasma fractionation, posing challenges to improve yield, maintain process economics, and manage regulatory requirements. Learn how the right partner can help fractionators to better serve patients globally with enhanced IgG, albumin, and Factor VIII products.
        Cell Therapy Manufacturing
        Introducing a new cell therapy demands optimal performance in upstream and downstream processing, process development, testing, and manufacturing. World-class products and partners are critical to success, speeding advancement of therapeutics that are effective, safe, and affordable.
        Gene Therapy Manufacturing
        Growing use of gene therapies is driving rapid innovation in an evolving global market. Manufacturers bringing new gene therapies to life face complex challenges, requiring an experienced partner capable of integrating vector manufacturing, testing, safety, process development, and regulatory compliance.
        Monoclonal Antibody Manufacturing
        Monoclonal antibody manufacturing is a highly templated approach used to produce mAb-based immunotherapies. Robust, scalable process solutions are required at every step to ensure high therapeutic concentration and process safety, while meeting speed-to-market and cost containment concerns.
        Vaccine Manufacturing
        From early phase development, through downstream purification to large scale vaccine production: learn more about vaccine process development and application expertise.
        Related Services
        Emprove® Filters and Single-Use Components
        Answering industry-wide demand for increased transparency, our Emprove® Filter and Single-use Components portfolio helps biopharmaceutical manufacturers advance their product development with confidence.
        Single-Use and Filter Validation Services
        Accelerate and simplify your path to market by using our BioReliance® Validation Services to select, test, and validate your filters, assemblies, and single-use systems for drug manufacturing and processing.
        Customer Collaboration Labs for Bioprocessing Optimization
        Optimize your biomanufacturing at M Lab™ Collaboration Centers, where customers explore, learn and collaborate to solve their toughest bioprocess challenges.

        Related Webinars

        Slide 1 of 6
        • EU GMP Annex 1 Draft - Closed System Design Consideration with Single Use Systems

          Webinar: EU GMP Annex 1 Draft - Closed System Design Consideration with Single Use Systems

          Biopharmaceutical manufacturing capacities have expanded dramatically which has resulted in an increased demand for single-use systems (SUS) as they have their own advantages. Although SUS are well established in the biopharmaceutical industry there is limited guidance on regulatory expectations. During this webinar we will focus on points to consider assuring sterility and integrity of a single-use assembly, and how collaboration between supplier and end-user can support the overall contamination control strategy of final filtration and filling operation.

        • Webinar: Regulatory Considerations including Extractables & Leachables for Single-Use Manufacturing

          Webinar: Regulatory Considerations including Extractables & Leachables for Single-Use Manufacturing

          A successful adoption of single use technology in a Biopharmaceutical process largely relies on the confidence in selection of such materials. Understanding the regulatory and industry expectations are important to streamline the implementation and approval process.

        • Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and Tomorrow

          Webinar: Upcoming USP 665 - Level of Characterization of Single-Use Systems Today and Tomorrow

          Single-use plastic systems are being utilized more frequently especially for COVID-19 vaccine manufacturing. However, there are issues regarding standardization of quality information that limits implementation efficiencies. One of the challenges is the evaluation of leachables derived from a variety of different plastic components in a timely manner.

        • Webinar: Process Equipment Characterization – How Standardized Extractables Data Support E&amp;L Risk Assessment

          Webinar: Process Equipment Characterization – How Standardized Extractables Data Support E&amp;L Risk Assessment

          This webinar will give an overview of the E&L evaluation workflow and practical study approaches from both supplier and end-user perspective, in accordance with the latest industry’s standards and upcoming USP <665> requirements. Case studies will be presented on how the data from suppliers are used to mitigate risk associated to SU materials, highlighting the key role of collaboration between the supplier and the drug manufacturer. 

        • Challenges using Multiple Single-use Systems: Functionality versus Extractables and Leachables

          Webinar: Challenges Using Multiple Single-Use Systems: Functionality Versus Extractables and Leachables

          A Single-Use System (SUS) is typically designed for a specific process step. In many cases, single-use components are chosen based on their functionality. The challenge arises when there are multiple processing steps- as the different applications and product matrices are evaluated, the complexity of the risk assessment increases. Complexity includes component evaluation, process conditions, and model solvents streams which ultimately relates to the patient safety risk.

        • Webinar: The Role of BPOG Extractables Data in the Effective Adoption of Single-use Systems

          Webinar: The Role of BPOG Extractables Data in the Effective Adoption of Single-use Systems

          The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.

        Related Videos

        Slide 1 of 7
        Sign In To Continue

        To continue reading please sign in or create an account.

        Don't Have An Account?