Director Syntegon Waiblingen, Baden-Wurttemberg, Germany
Despite the benefits of DoE, the execution of the planned experiments is often a major challenge. Even with statistically optimized planned experiments, still many experiments have to be executed, i.e., to determine interactions. We propose to perform such experiments with a high automation level. The machine adjusts all process parameters automatically and all or at least most of the critical quality attributes are measured directly in or at the system. The experiments are executed automatically without or with only reduced human interaction. As a result, several experiments can be executed in a reduced amount of time. Human errors like a missed experiment or wrong data transfer are prevented. Processes can easily be better understood by applying a combination of automation and DoE. The presentation will describe the method for capsule filling and tablet compression. Examples and results from formulation development, process optimisation and continuous manufacturing line.
identify a new, efficient and fast process to increase quality and efficiency, decrease cost and development effort for capsule filling and tablet compression
understand why the combination of DoE, measuring of quality attributes and automated testing is new and generic approach
see the new approach combining DoE and a high level of automation as a valuable option for today’s pharmaceutical industry
Automated process development offers an simple and efficient way to optimize processes