Mobius® Essential Assemblies by Merck – Reliable Single-Use Bag and Tubing Solutions for Pharma & Biopharma Manufacturing

Mobius® Essential Assemblies by Merck – Reliable Single-Use Bag and Tubing Solutions for Pharma & Biopharma Manufacturing

Pharma and biopharma manufacturing demands efficiency, sterility, and compliance at every stage. Mobius® Essential Assemblies by Merck offer ready-to-ship, standardized single-use bag and tubing solutions made with PureFlex™ film, streamlining fluid management and enabling easy integration into existing processes. Discover how these assemblies eliminate lead times while supporting scalable, compliant production.

Benefits of Mobius® Essential Assemblies

  • Ready-to-ship availability: Eliminates design and manufacturing lead time, allowing immediate deployment into your bioprocessing workflow.
  • Plug-and-play integration: Easily integrates into current processes without requiring process redesign or additional engineering effort.
  • Clear scalability pathway: Provides a straightforward route to scale up to Mobius® MyWay premium assemblies, supporting process growth without starting from scratch.
  • Compliance confidence: Supported by the Emprove® Program, which provides access to reliable technical, regulatory, and supply information through Emprove® Dossiers to support your risk assessment continuum.
  • Simplified validation effort: The use of a single film type across the full drug manufacturing process limits the validation and implementation burden across multiple process steps.

Features of Mobius® Essential Assemblies

  • Assembly format: Standard, off-the-shelf single-use bag and tubing assemblies designed for immediate use in bioprocessing environments.
  • Film material: Constructed with PureFlex™ film, a high-purity, coextruded film validated for use across multiple stages of drug manufacturing.
  • 2D bag configurations: Available in 2D bag format ranging from 1 L to 50 L, covering small- to mid-scale process volumes.
  • 3D bag configurations: Available in 3D bag format ranging from 100 L to 200 L for larger-scale bioprocessing requirements.
  • Tubing assemblies: Offered as standalone tubing assemblies with connector options including End Ported Connector (Manifold), AseptiQuik® G Connector (Manifold), and MPC Connector.
  • Gamma irradiation: Each assembly is irradiated at a gamma irradiation level of 25–40 kGy to ensure sterility.
  • Visual inspection: Each assembly undergoes visual inspection for appearance and cleanliness prior to shipment.
  • Quality classification: Categorized as MQ300 within the M-Clarity™ Program and manufactured under an ISO 9001 Quality System Standard.

Technical Specifications of Mobius® Essential Assemblies

SpecificationDetails
IrradiationEach assembly was exposed to a gamma irradiation level of 25–40 kGy
QualityISO 9001 Quality System Standard, categorized MQ300 within the M-Clarity™ Program
Biological ReactivityUSP <88> Class VI, post-gamma irradiation
Appearance and CleanlinessEach assembly is visually inspected

Applications of Mobius® Essential Assemblies

  • Media and buffer preparation: Used for the preparation and containment of media and buffer solutions at various process scales.
  • Cell culture: Suitable for use as fluid management containers during cell culture operations.
  • Purification: Applied in fluid handling and storage steps within downstream purification workflows.
  • Product intermediate storage and mixing: Used to store and mix product intermediates between process steps.
  • Sterile sampling: Supports sterile sampling requirements at critical points throughout the manufacturing process.
  • Drug product filling: Applicable in the final drug product filling stage, supporting end-to-end single-use fluid management.

Mobius® Essential Assemblies Product Range

Part NumberProduct DescriptionPack Size
ESA0001L2CLP10Mobius® Essential Assembly, 1 L bag with PureFlex™ film10
ESA0005L2CLP5Mobius® Essential Assembly, 5 L bag with PureFlex™ film5
ESA0010L2CLP5Mobius® Essential Assembly, 10 L bag with PureFlex™ film5
ESA0020L2CLP5Mobius® Essential Assembly, 20 L bag with PureFlex™ film5
ESA0050L2CLP5Mobius® Essential Assembly, 50 L bag with PureFlex™ film5
ESA0100L41DP5Mobius® Essential Assembly, 100 L bag with PureFlex™ film5
ESA0200L41DP5Mobius® Essential Assembly, 200 L bag with PureFlex™ film5
EST0000L06EP5Mobius® Essential Assembly, Tubing with End Ported Connector, Manifold5
EST0000L06GP5Mobius® Essential Assembly, Tubing with AseptiQuik® G Connector, Manifold5
EST0000L02CP5Mobius® Essential Assembly, Tubing with MPC Connector5

With over 23 years of expertise, Chemical Express is the official distributor of Merck in Thailand. You can order Mobius® Essential Assemblies and other high-quality Merck products for your pharma and biopharma manufacturing needs through Chemical Express, ensuring expert support and access to the complete product range.

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