Continuous Manufacturing Of Pharmaceuticals

For more than 50 years, pharmaceuticals have been produced via batch manufacturing, which requires multiple steps and the use of large-scale equipment. Recently, however, many in the pharmaceutical industry have begun moving away from batch manufacturing to continuous manufacturing. The FDA is now taking proactive steps to facilitate the drug industry’s implementation of emerging technologies, including continuous manufacturing, to improve product quality and address many of the underlying causes of drug shortages and recalls.

In a continuous manufacturing process, it is often difficult to aggregate data to perform analytics across multiple assets, including process analytical technology (PAT) tools. In addition, continuous monitoring of key performance indicators (KPIs) in near-real time is necessary to maintain the process within the desired design space. KPI monitoring is also needed to enable process adjustments prior to any variables trending outside of the design space.

A pharmaceutical company was finding it difficult to aggregate data and perform analytics across multiple assets, as well as monitor KPIs for continuous pharmaceutical processes in near-real time. The company needed a dashboard to track and monitor the process parameters and identify deviations when they occur. This solution allowed the company’s quality engineers to create a continuously updating operational dashboard to monitor KPIs.