Are you sure of the robustness of your process?
Development of robust procedures for a safe scale-up and industrial production.
Once a procedure is optimised, proving its robustness is the next step forward in order to assure a reliable scale-up and transfer to industrial production.
As the guideline ICHQ8 points out “Design Space is the multidimensional combination and interaction of input variables and process parameters that have been demonstrated to provide Assurance of Quality”. A robustness test is key to find this Design Space. Among other possibilities, we have chosen to use Design of Experiments as a tool in order to prove the robustness of a process. Other issues such as reaction mixing, kinetics, etc, are also taken into account in our scalability studies.