Single-Use Assemblies

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^® SELECT

MOBIUS^® CHOICE

Off-the-Shelf Standard Assemblies

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

Highly Customized Solutions

Mobius^® Assembly Certification and Release Testing

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.

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

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™ 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.

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

Related Webinars

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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.
Webinar: Process Equipment Characterization – How Standardized Extractables Data Support E&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.
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: 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: 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.