Optimized Buffer Formulation
Optimized buffer formulation can have a significant impact across downstream operations. The Flexsafe® Pro Mixer combines speed and efficiency to deliver high performance mixing and dissolving buffer powders even in worse-case conditions such as high volume and high concentration, making the buffer preparation step quick and easy to perform.
The Flexsafe® Pro Mixer supports efficiency and quality through the media formulation process steps:
- Buffer 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 buffer powder or concentrated liquid buffer is added. Because buffer 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, conductivity 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 buffer is sterile filtered and stored before further use for drug substance purification or final drug product formulation.
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 intermediate, 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 buffer formulation uses single-use and integrated sensors for the in-line control/monitoring of pH, conductivity and temperature during buffer 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 buffer 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 and quick coupler connector and drain valves to prevent powder accumulation in bottom-mounted tubing.