Optimized Media Formulation
Optimized media formulation can have a significant impact across upstream operations. The Flexsafe® Pro Mixer combines speed and efficiency to deliver high performance mixing during media powder dissolution.
The Flexsafe® Pro Mixer supports efficiency and quality through the media formulation process steps:
- Media formulation process involves filling the mixer with water for injection (WFI) up to 60% to 80% of the final volume. To accelerate the dissolution, the WFI can be heated with Flexsafe® Pro Mixer’s heat-exchange jacket.
- After starting the mixing drive unit, the media powder or concentrated liquid media is added. Because media powders tend to float, the Flexsafe® Pro Mixer’s strong vortex ensures downward entrainment to the impeller and subsequent dissolution.
- Once the dissolution is complete, WFI is added to adjust to the final volume. The Flexsafe® Pro Mixer’s weighing control allows this adjustment to be performed automatically.
- Temperature and pH can be monitored and adjusted in-line, and process samples are taken off-line for other QC tests.
- When the formulation is complete, the media is filtered for sterilization and mycoplasma removal and stored before further transfer to the bioreactor.
Building on more than 20 years’ experience designing Single-use Fluid Management Solutions, we established Pre-Designed Solutions (PDS) to offer simple, safe, fast and more affordable supply chain options. For every media, buffer, harvest, downstream intermediates, drug substance and drug product process step, Flexsafe® Pro Mixer PDS assure consistent quality and robust change control.
The Flexsafe® Pro Mixer Pre-Designed Intelligent Solution for media formulation uses single-use and integrated sensors for the in-line control and monitoring of both pH and temperature during media formulation, as required for cGMP biomanufacturing. These integrated features reduce operator time and the margin for error.
PDS Without Single-Use Sensors
The Flexsafe® Pro Mixer Pre-Designed Solution for media formulation offers also the flexibility to employ reusable sensors via the 8” top opening for in-line controls, or sampling in single-use bags for off-line controls. Samples can be taken via an additional Tuflux® Silicone line equipped with a clave needleless sampling port. Filling and draining lines are available with Tuflux® Silicone tubing and Tri-Clamp 1 1/2” sanitary flange. Additional options include lines for liquid additions with Tuflux® Silicone tubing with quick coupler connector and drain valves to prevent powder accumulation in bottom-mounted tubing.