(649e) Use of Statistical Process Control to Drive Process Improvements in Continuous Manufacturing

Statistical process control (SPC) tools such as control charts and process capability analysis are used in the manufacturing industry to continuously monitor process trends, identify out of trend (OOT) results and evaluate changes to the process. The use of SPC tools is a key element in the implementation of continued process verification for commercial . Failure to identify out of trend results can potentially impact the quality of pharmaceutical products.

The implementation of online process analytical technology (PAT) tools in continuous processes enables real-time monitoring of the process and provides large data sets that constitute both spectroscopic and non-spectroscopic data. In this work, SPC tools were used to evaluate the process performance, understand process variability and identify opportunities for process improvement. Control charts and process capability analysis were used to identify trends in the process parameters and anticipate out of specification results in a pharmaceutical continuous tableting process. Identification of in-process parameter outliers, and effectiveness evaluation of process improvements are demonstrated through case studies.