Speed and efficiency of clinical scale TFF development is enhanced by single-use systems (SUS). Their design is greatly simplified by eliminating pipework and features for CIP/SIP and optimizing flow paths, enabling ultra-low minimum working volumes under 0.5 L/m2.   The current focus on characterizing mixing performance in the MilliporeSigma SU-TFF system, which uses a modified Mobius Mix system as the retentate vessel, will aid end-users with process integration.  Low and high VCF process simulations were carried out at low and high viscosity (1, 25 cP) to understand mixing behavior and the time required for a pulse addition of 1 or 5 M salt solution.  Blend time was a function of total (pump + impeller) flow rate. Comparing turnover volumes to achieve homogeneity gives a measure of mixing efficiency (# pump + impeller passes). Higher system volumes are more efficient.

Process simulations in a clinical scale single-use TFF system examine blend time efficiency

255th National Meeting (2018)

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