Millipore Mobius Sample Disposable Assembly 500L Single Use Gold Certification

The Millipore Mobius MIX0500LSG04 is a high-performance, single-use mixing assembly designed for the sterile handling and sampling of pharmaceutical and biological fluids. Specifically engineered for use with the 500L Mobius Mix system, this "Gold" certified assembly ensures maximum process security and reproducibility. It leverages Millipore’s PureFlex film technology and integrated magnetic impeller to provide efficient, low-shear mixing of buffers, media, and intermediate drug products.

Technical Performance and Design

• Magnetically Driven Impeller: Features a bottom-mounted, levitating magnetic impeller that eliminates the need for mechanical shafts or seals, significantly reducing the risk of leakage and contamination.

• PureFlex Film Technology: The container is constructed from high-durability PureFlex film, a multi-layer material known for its excellent gas barrier properties, low extractables, and high mechanical strength.

• Gold Certification Level: Represents the highest tier of manufacturing quality, including 100 percent leak testing of the assembly and comprehensive lot-specific documentation to support regulatory compliance.

• Needle-Free Sampling: Equipped with specialized needle-free sample ports that allow for the extraction of representative samples without compromising the closed, sterile environment.

Product Specifications

• Part Number: MIX0500LSG04

• Nominal Volume: 500 Liters

• Product Line: Mobius MIX Single-Use

• Materials: PureFlex container, Polypropylene impeller, Nylon and PVDF clamps

• Operating Temperature: 4C to 30C (non-condensing)

• Sampling Ports: Integrated needle-free ports (Gold configuration)

• Dimensions: Approximately 42 x 37 x 37 inches (H x W x D)

Operational Advantages

• Zero Dead-Leg Sampling: The unique design of the sample ports ensures that samples are representative of the entire 500L batch, minimizing the loss of valuable product during the sampling process.

• Rapid Setup and Turnaround: As a single-use solution, this assembly eliminates the labor-intensive Clean-In-Place (CIP) and Steam-In-Place (SIP) cycles, allowing labs to switch between batches in minutes.

• Scalable Performance: The Mobius Mix technology provides predictable mixing dynamics across the entire product family, facilitating a smooth transition from process development to large-scale manufacturing.

• Closed System Integrity: The fully integrated tubing and connectors maintain an aseptic environment throughout the mixing and sampling stages, protecting sensitive biopharmaceutical ingredients.