2D Pillow-style Single-use Assemblies
Mobius® 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 Assemblies
Mobius® 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.
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.
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|
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.
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||Shelf Life Claim**||Sterility Claim||LAL & Particulate||Leak Testing||Class VI USP (88)|
|Gold||2 years||Sterile, Quarterly Validation||Lot Release||100% of lot on full assembly & bag*||Post-gamma, component family|
|Silver||2 years||Sterile, Quarterly Validation||Quarterly review of results||In-process leak testing||Post-gamma, component family|
|Bronze||None||Gamma-irradiated >25 kGy, not validated sterile||No testing performed||No testing performed||Pre-gamma resin only|
|Basic||None||None||No testing performed||No testing performed||Pre-gamma resin only|
|* Complete assembly testing is performed unless prohibited by the design.
** The stability study supports a shelf life on the whole assembly (post gamma) for sterility and functionality for up to 2 years provided all components on the assembly have a minimum of 2 years shelf life left at the time of the manufacture of the product. Although Mobius® manufacturing strives to offer a 24 months life before expiration, there are instances when certain components may not have 2 years shelf life prior to manufacture of an assembly and the expiration date of the whole assembly is adjusted based on the component with the shortest shelf life.