(238b) Practical Methods for Process Scale-up

Process scale-up in batch and semi batch industry (specialty chemistry, fine chemicals, active pharmaceuticals ingredient and many others) is characterized by a high level of uncertain and unexpected results. It is common to have processes where the purity of the final material and the in- process control tests are not reaching the specifications coming from the R&D procedures. As a result of this inconvenient situation, process transfer activities become difficult. In the R&D stage, the focus is to understand the mechanism of the process. whereas in the process transfer stage, the main target is to provide the conditions for the process in order to achieve the same results in yield and quality at all steps of the process. On the other hand, at the process transfer stage, quality of the raw materials and procedure of the process is well known, and normally is not the place to change them. As a consequence, the only reason for different results should come from the size of the equipment and from the different geometries used for the process in the upscale. It is clear from this forced change in the geometry, that the conditions provided to the process will change because of the difference in the flow generated at different sizes or geometries. It is also clear, that the process is progressing into the flow. So, if we will be able to identify which mixing parameters are significant for the process we will be able to avoid undesirable results.

In this presentation, we will discuss how to generate a good set of calculations and experiments that will provide a deep understanding of the scale up parameters that affect the process by understanding of the influence of the fluid dynamics and the mixing of the process.