Mobius® 2D and 3D Assemblies and Storage Systems
Safe, Effective Product Storage
Mobius® 2D and 3D Assemblies and Storage Systems are key components in delivering efficient, ergonomic and scalable process solutions to your production floor. For multiple applications in single-use manufacturing operations, these systems consist of a series of PE drums, stainless steel bins, collapsible bins, and 2D and 3D single-use assemblies. Mobius® Assemblies and Storage Systems are designed to reduce operator error and improve process efficiency. With a full spectrum of systems to choose from, you get greater flexibility, mobility and support for your single-use technologies.| Mobius® MyWay Portfolio | Assemblies | Storage Systems, Bins, Drums | Single-Use Bioprocessing Films | Emprove® Program |
Mobius® 2D and 3D Assemblies
Standard AssembliesPurchase standard assemblies off the shelf for faster turnaround time and reliable performance. Each package includes a Mobius® Silver Certificate of Quality.
Mobius® Essential AssembliesMobius® Essential Assemblies are standard, off-the-shelf, simple bioprocess bag and tubing assemblies that are ideally suited for all your non-critical applications. These plug-and-play assemblies are made of our proven PureFlex™ film and are available in both 2D bags (1 L - 50 L), and 3D bioprocess bags (100 L – 200 L), as well as bioprocess tubing assemblies.
Mobius® 2D Freeze Assembly for Frozen Liquid Transportation and Storage
Available in 1 L, 5 L, 10 L, and 20 L sizes, the standard Mobius® 2D Freeze assembly is made with our PureFlex™ film and is Helium integrity tested to assure integrity will be maintained at temperatures down to -80 °C. This solution enables easy and safe storage and transportation of your valuable product between multiple sites providing flexibility and security to your processes.
2D Pillow-style Single-use AssembliesMobius® standard, pillow-style assemblies, sterilized and ready to use in a wide range of biopharmaceutical applications, such as formulation, sampling and storage of sterile solutions. Available in volumes from 50 mL to 50 L, they feature the container, tubing, fittings and Merck’s patented NovaSeal™ sealing technology for secure, sterile disconnection.
The containers also feature end-hangers for easy lifting, and pinch clamps on each line.
3D Drum-style Single-use AssembliesMobius® standard drum assemblies are convenient, single-use solutions for a wide range of biopharmaceutical applications, such as storage and processing of sterile fluids or buffer. Available in volumes from 50 L to 200 L, they feature a PureFlex™ and PureFlex™ Plus single-use films, fittings, C-Flex® and silicone tubing with pinch clamps on each line.
The containers are specifically designed to fit Mobius® polyethylene drums but work just as well with other commercially available plastic storage drums.
Configured:
Create a vast array of single-use process solutions by selecting off-the-shelf parts from our standard library of components, including our process containers, filters, and connectors and tubing.
Custom:
We can design, develop and integrate custom components specifically engineered to fit your applications and specifications. Contact us for more information.
Backed by the quality, services and support you expect from Merck, Mobius® single-use assemblies offer superior quality and safety, and help accelerate time-to-market.
Quality Assurance and Certification Levels
Each Standard Assembly package includes a Mobius® Silver Certificate of Quality.
| Shelf Life Claim | Sterility Claim | LAL & Particulate | Leak Testing | Class VI USP (88) |
| 2 years | Sterile, Quarterly Validation | Quarterly review of results | In-process leak testing | Post-gamma, component family |
Quality Assurance
Mobius® assemblies are produced in Merck facilities that adhere to cGMP. Family component materials have been tested post-gamma irradiation and meet criteria for USP <88> Biological Reactivity Test for Class VI plastics. Leak integrity testing, using a pressure decay method on each lot, ensures product quality. Every Mobius® assembly comes with a quality guarantee for material and workmanship.
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 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 Integrity Test Data Sheet.
Certification Levels
You demand quality, cost containment and regulatory compliance at every stage of process development. With Gold, Silver and Bronze certification levels, you can select the option that’s right for you:
| 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 Integrity Test | 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 |
With a full spectrum of systems from which to choose, you get greater flexibility, mobility and support for your single-use technologies.
Mobius® Storage Systems, Bins and Drums
Mobius® offers a range of options for product storage, transfer, handling and transport, including:
Polyethylene Drums and Bins:These polyethylene drums are designed for the use and storage of media and buffer solutions in process-scale disposable manufacturing applications.
Available in 50 L, 100 L and 200 L sizes, the stackable drums hold single-use standard assemblies with both top and bottom container port arrangements, including those with filter capsules attached to tube sets in sterile applications. Supported by an optional dolly.
Collapsible Bins:These easy-to-use storage vessels are designed to handle process containers from 250 to 1,000 L during various manufacturing stages, ranging from buffer preparation and media delivery to final product formulation.
- Stackable and collapsible for easy storage when not used
- Provide optimal space utilization in a crowded clean-room
Stainless Steel Bins:Designed for convenient handling, Mobius® stainless steel bins offer an advanced solution for the use and storage of media, buffer and additional intermediates in the biopharmaceutical manufacturing process.
Available in a broad range of standard configurations - from 200 L to 1500 L - the bins accommodate a range of process containers from Mobius® and other manufacturers.
- Single, large door that facilitates easy access and process container positioning
- 304/304L stainless steel construction
- Convenient slide-out tray
- Easy folding design that eliminates need for operator or mechanical assistance during filling
- Animal-derived component-free materials in single-use construction