Skip to Content

Home Products Pharma & Biopharma Manufacturing Fluid ManagementSingle-Use Assemblies

Single-Use Assemblies

Ready-to-ship Single-use Assemblies Help Meet Your Challenging Timeline

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

Need help to find the right Mobius^® Essential Assemblies for your processing needs? Fill out a short form to connect with our single-use specialist today.

Request More Information

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.

Request More Information

Mobius^® Stock

Icon with a turquoise hexagonal chain design inside a shield-like shape.

Mobius^® Select

Icon featuring interconnected geometric shapes including hexagons and triangles within a shield-like shape

Mobius^® Choice

Icon with three upward arrows inside a shield-like shape

Off-the-Shelf Standard Assemblies

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

Highly Customized Solutions

Mobius^® Assembly Certification & 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.

Certification Level	Shelf Life	Sterility	USP <85> Endotoxins, USP <788> Sub-visible Particulates	Leak Testing	USP <88> Biological Reactivity in vivo (Class VI), USP <661> Physicochemical Tests
GOLD + HELIUM	2 years	Sterilized using a validated gamma irradiation level of 25-40 kGy	1 assembly per lot tested, post-gamma irradiation	100% assembly helium integrity tested	Post-gamma irradiated
GOLD	2 years	Sterilized using a validated gamma irradiation level of 25-40 kGy	1 assembly per lot tested, post-gamma irradiation	100% assembly leak tested	Post-gamma irradiation
SILVER	2 years	Sterilized using a validated gamma irradiation level of 25-40 kGy	Quarterly review of results, post-gamma irradiation	In-process testing	Post-gamma irradiation
BRONZE	No claim	Exposed to gamma irradiation level of 25-40 kGy	No testing performed	No testing performed	Pre-gamma irradiation
BASIC	No claim	Non-sterile	No testing performed	In-process testing	Pre-gamma irradiation

Single-use Film Technology

Slide 1 of 2

Cross-section of layered packaging material, with labels indicating each layer’s composition and purpose.

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.

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.

Contact Our Technical Expert

Mobius^® Single-use Assemblies are Supported by the Emprove^® Program – The Smart Way To Master Compliance And Control

Complementing our product portfolio, the Emprove^® Program provides convenient access to reliable technical, regulatory and supply information in Emprove^® Dossiers to support your risk assessment continuum. Our Advanced Qualification Dossier is customized with specific information for your single-use assembly.

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 Millipore^® validation services.

Related Resources

Application Note: Deviron^® Detergents for Viral Inactivation
Deviron^® C16 and Deviron^® 13-S9 Detergents for Solvent/Detergent Viral Inactivation of Plasma in Mobius^® Single-Use Containers
Brochure: Single-use Fluid Management
2D & 3D assemblies, filtration, storage, and transportation solutions
Application Note: Higher Volume Processing Using Natrix^® Q Device
This application note describes a series of tests to assess performance of a Mobius^® tubing assembly containing two Natrix^® Q Process 600 devices manifolded in parallel.
White Paper: The Role of BPOG Extractables Data in the Effective Adoption of Single-use Systems
Single-use systems are increasingly popular in biomanufacturing. Their adoption offers numerous advantages for greater efficiency and productivity in applications such as final filtration, mixing and aseptic connections.
Technical Brief: Shipping Qualification of Mobius^® Large Liquid Transportation according to ISTA
Safe and efficient transportation of your large bulk liquid substances is critical. These liquids could include sterile water, buffers, media, intermediates, bulk drug substances and final drug products. Therefore, we completed an extensive ISTA shipping validation to provide the safest transportation for your critical bulk liquids.
White Paper: Single-Use Upstream Processing: Ultimus^® Film Delivers Comparable Cell Growth Performance To Glass
Single-use technologies are increasingly being incorporated into the biomanufacturing workflow to achieve greater efficiency and productivity, reduce capital investment in facilities and equipment, and minimize the risk of cross-contamination.
Infographic: Prevent Costly Bag Leaks in Single-Use Manufacturing
The Ultimus^® Film Difference Designed with a proprietary woven nylon structure, Ultimus^® film demonstrates superior strength and resilience to protect against leaks, abrasions, tears and material fatigue.
Technical Brief: Demonstrated Strength and Durability of Ultimus^® Film
Single-use technology is used for different operations throughout biomanufacturing including mixing, storage and transportation.
Spec Sheet: PureFlex™ Single-Use Process Container Films
PureFlex™ film is used to construct our Mobius^® single-use assemblies and Novaseptum^® sampling bags. These single-use products are used in biopharmaceutical processes, improving efficiency and productivity while reducing the risk of contamination.
Spec Sheet: Ultimus^® Film
Ultimus^® film was designed to meet the needs of more challenging single-use applications such as large-volume liquid processing. Our Ultimus^® film technology provides enhanced bag strength, improved durability and leak resistance through a novel strength layer reinforced by woven nylon.
Data Sheet: Mobius^® 2D Freeze Assembly
Mobius^® 2D Freeze Assembly Data Sheet
Spec Sheet: Mobius^® Essential Assembly
Mobius^® Essential Assembly Spec Sheet

Page 1 of 3

Related Webinars

Slide 1 of 6

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

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.

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&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: 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

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.

Sign In To Continue

To continue reading please sign in or create an account.

Don't Have An Account?

An unknown error has occured.