Enhancement of the process validation via characterization and optimization of mixing operations in the Sanofi Pasteur cutting-edge manufacturing facility designed for the production of 5-component acellular Pertussis, Diphtheria, and Tetanus vaccines
Sanofi Pasteur has established a cutting-edge facility for the production of different types of vaccines in Toronto. This state-of-the-art facility is comprised of various complex mixing operations, which play significant role in the vaccine production. Currently, there is lack of sufficient information about the hydrodynamics of these mixing units for the process validation. In this project, computational fluid dynamics and tomography will be utilized to characterize and optimize the operations of mixing units. The CFD model will be validated using tomography data. The validated CFD model and tomography data will be employed to assess the effects of different design parameters and operating conditions on the performances of these mixing units, which enable us to determine the optimal conditions. The implementation of CFD modelling in the process validation will result in reducing the process validation time and cost by at least 80% resulting in a major cost saving of over $400,000.