Watson-Marlow Fluid Technology Group has supplied peristaltic pumps to Novasep for its Sius™ TFF skid, a tangential flow filtration (TFF) system used in the biopharmaceutical industry.
The system separates and concentrates biomolecules according to their size.
Watson Marlow’s 520UN/R2 and 620UN/RE pumps were selected to facilitate the system’s fluid transfer operations.
A 100% single-use TFF solution
In TFF, the fluid circulates across a porous membrane. Pressure is applied to pass fluid through the membrane, and molecules of a greater size than the pores remain in the retentate. Small molecules pass through into the permeate.
The retentate loops continuously back through the membrane, which enables the molecules to be concentrated or facilitates buffer exchange (diafiltration).
Recirculation as a part of diafiltration
The rententate loop is fed by Watson-Marlow’s 520UN/R2 continuous tubing pump. As part of diafiltration, it delivers replacement buffer to stream.
A 620UN/RE LoadSure tube element pump is used to recirculate the retentate within the loop by providing low-pulse flow rates and a linear 4bar displacement pressure. This pressure enables easy setting of the system rentate valve.
These two pumps provide an advantage by ensuring that cells are not damaged by excessive heat transfer. They also keep unwanted particulates from the fluid stream. Peristaltic technology eliminates cross-contamination risks.
"In this type of application, purity and quality are key factors," says Mr Chevalier, Process Engineer at Novasep. "Therefore, the cleaning phases are very important in order to ensure that the equipment complies with hygiene specifications. The Watson-Marlow pumps’ tubing provides high-purity USP Class VI validated contact materials.
Watson-Marlow tubes are pre-sterilised with gamma radiation so the user can eliminate the cleaning and validation phase without risk of contamination. This saves a great deal of time and has a direct effect on operating costs.
Accurate fluid delivery
"The second advantage of Watson-Marlow’s pumps is that they offer a high degree of precision, even at higher pressures," adds Mr Chevalier. "This has enabled us to leave out the flow meter that we had planned originally."
Novasep, which has its global headquarters in Pompey, France, supplies products for the manufacture of synthetic molecules and biomolecules used in the pharmaceutical industry.
The company’s Sius™ TFF skid is composed entirely of single-use components, all of which are pre-sterilised and ready to use. Novasep has also developed a system to facilitate the performance of integrity tests that validate the assembly in-situ.
Sius™ TFF skid covers all tangential filtration requirements from the research and development stages through to commercial production thanks to its compact design and available range (0.1-2.0m²).
The system has been developed completely by Novasep and is supplied with all the validations required to work in a Current Good Manufacturing Practices (CGMP) environment.