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Flexsafe® Pro Mixer Bag 100L

The Flexsafe® Pro Mixer is a unique, single-use mixer that can accommodate a wide range of mixing steps in both upstream and downstream processes.

Flexsafe® Pro Mixer technology combines speed and efficiency to deliver high performance mixing during powder dissolution and a levitating impeller to preserve the drug during low shear blending applications. Its ergonomic design enables intuitive, modular and agile use to achieve fast installation and operational excellence.

The Flexsafe® Pro Mixer provides the high levels of control that are essential for cGMP biomanufacturing.

Item no.:  FMS500103

   

Building on 20 years of experience in single-use fluid management solutions, Flexsafe® Pro Mixer Predesigned Solutions have a proven history of process optimization in a variety of applications —from buffer and media preparation to downstream steps and final formulation.

The ergonomic design of the Flexsafe® Pro Mixer 50–3000 L offers ease of handling:

  • The Flexsafe® Pro Mixer Bag (50–1000 L) contains a central magnetic impeller assembly. Its unique sided K-weld design simplifies installation and facilitates the unfolding and folding of the bag during filling and draining operations. The 8” diameter top port allows easy and contained powder transfer into the mixing bag during buffer and media applications.
  • The Flexsafe® Pro Mixer Bag (1,500 to 3000 L) contains an off-center magnetic impeller assembly and a 4” top port for powder transfer. Its bottom and top K-welds, combined with the Palletank lifting system, facilitates bag installation as well as filling and emptying operations.
  • The positioning of the tubing lines and sensors allow for easy installation and direct access during filling, sampling and draining.

The Pro Mixer bag featuring the Flexsafe® film provides consistent process validation data with sustainable, reproducible and reliable data for Extractable and Leachable (E&L), toxicology and stability studies cost-efficient process validation robustness, consistent quality and assurance of supply.

Inline control and monitoring of pH, conductivity and temperature are performed with a preassembled single-use pH probe, conductivity sensor and thermowell. Inline sensors meet PAT and cGMP requirements, eliminate the risk of contamination associated with reusable probes and reduce operator time.

Building on 20 years of experience in single-use fluid management solutions, Flexsafe® Pro Mixer Predesigned Solutions have a proven history of process optimization in a variety of applications —from buffer and media preparation to downstream steps and final formulation.

The ergonomic design of the Flexsafe® Pro Mixer 50–3000 L offers ease of handling:

  • The Flexsafe® Pro Mixer Bag (50–1000 L) contains a central magnetic impeller assembly. Its unique sided K-weld design simplifies installation and facilitates the unfolding and folding of the bag during filling and draining operations. The 8” diameter top port allows easy and contained powder transfer into the mixing bag during buffer and media applications.
  • The Flexsafe® Pro Mixer Bag (1,500 to3000 L) contains an off-center magnetic impeller assembly and a 4” top port for powder transfer. Its bottom and top K-welds, combined with the Palletank lifting system, facilitates bag installation as well as filling and emptying operations.
  • The positioning of the tubing lines and sensors allow for easy installation and direct access during filling, sampling and draining.

The Pro Mixer bag featuring the Flexsafe® film provides consistent process validation data with sustainable, reproducible and reliable data for Extractable and Leachable (E&L), toxicology and stability studies cost-efficient process validation robustness, consistent quality and assurance of supply.

Inline control and monitoring of pH, conductivity and temperature are performed with a preassembled single-use pH probe, conductivity sensor and thermowell. Inline sensors meet PAT and cGMP requirements, eliminate the risk of contamination associated with reusable probes and reduce operator time.

  • Additional Lines
    2 bottom lines: ⅜" ID Silicone TuFlux® 1.5 m (60") + MPC female + sealing cap
  • Application Area
    Mixing
  • Aseptic Connector Device
    No
  • Connector Inlet
    ½" ID Silicone TuFlux® 1.5 m (60") + ½" Tri-Clamp 1½" sanitary flange with gasket, cap & union
  • Connector Outlet
    ½" ID Silicone TuFlux® 1.5 m (60") + ½" Tri-Clamp 1½" sanitary flange with gasket, cap & union
  • Drain Valve
    No
  • Film Material
    Flexsafe® film
  • Filter
    No
  • Gas Barrier Layer Material
    Ethylene vinyl alcohol (EVOH)
  • Pack Size
    1
  • Process Step
    Drug Product Formulation
  • Product Contact Layer Material
    Polyethylene (PE)
  • Sampling Lines
    ¼" ID Silicone TuFlux® 0.1 m (4") + Clave needleless sampling port
  • Sensors
    No
  • Sterilization Method
    Gamma irradiation
  • Tubing
    Silicone
  • Type
    Flexsafe® Pro Mixer Bag
  • Volume
    100 L
  • pH Adjustment Lines
    No
  • pH Sensor
    No
Pro Mixer Drive unit
Pro Mixer Drive unit
Item no.: FMD300001

The Pro Mixer drive unit levitates and rotates the single-use magnetic impeller in the mixing bag with no surface contact.

The Pro Mixer drive unit features automated control of the mixing parameters, offers a user-friendly touchscreen interface and can manage multiple Palletank for Mixing units.

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