PAT & synTQ for API Production
A leading pharmaceutical manufacturer installed synTQ® for use on a reactor system that was producing an API product using an exothermic reaction. The existing process cannot determine the status of the critical to quality attributes until the end of the process, and the quality verification process at the end of production resulted in a great deal of waste. As the product is costly this results in a very expensive process. synTQ® was installed together with multivariate analysis products from CAMO and suitable instruments, and together these enabled the client to build their process model. After testing the model the client introduced real time control using the Orchestration features within synTQ®, an OPC connection and a 3rd party control system. We understand that using his process understanding, the output of real time critical to quality attributes and synTQ® the client was able to control the process in real time to optimise the quality and bring wastage to a minimum. We understand that the payback period was less than 2 batches.