Manufacturing and Bioprocessing
2019 PharmSci 360
For understanding a process all the influences on the process need to be determined, interactions are described and the outcome product quality is predictable. To achieve this, planning of the experiments with Design of Experiments (DoE) is very helpful.
The execution of the planned experiments is often a major challenge, because of the high number of experiments which have to be executed, i.e. to determine interactions. We present with a high automation level of a capsule filling machine for all process parameters. A full design space screening can be performed in 2 hours with less material consumption. Outstanding better results for complex powders, formulation development with different excipients, development of continuous manufacturing processes or inhalation products compared to the classic approach are presented.
The new approach combining DoE and a high level of automation is a valuable option for other manufacturing processes and today’s pharmaceutical industry.