Innovation in the Pharmaceutical Industry

When DeltaV Predict (embedded model predictive control, MPC) was introduced in 2001, I developed some of the MPC lecture material and process simulations that are used in our advanced control education class, 7201. Also, I helped teach the first three of four classes. I always enjoy teaching in these types of classes since of the customers who attend this training often represent a variety of industries. In one of one of the classes, a student showed a particularly strong interest in MPC and discussed several areas of his process that would benefit from this technology. It turned out that the student was the head of instrumentation at a Pharmaceutical plant in Puerto Rico.

A few months after this class, our service department received an order from this pharmaceutical customer to install MPC in one process area. Since DeltaV Predict was new to our service organization, the advanced control team provided some support in the implementation and startup of this MPC application. The savings from this one application were substantial (in the seven digits) since the area was a bottleneck in plant production. We later shot a video at the plant site. In this video the customer discusses the installation and the benefits they realized for this installation of MPC technology.

Making a control change, such as the installation of MPC, in a pharmaceutical installation was at that time complicated by the fact that the target process was an existing validated installation. Fortunately, our service department had done the original installation and thus was very familiar with the regulator submissions needed to make this change in the process control. However, the paper work required to make this improvement using proven embedded technology still took a consider amount of work and time. Because of this paperwork, many manufacturing procedures in the pharmaceutical industry are often treated as being unchangeable.

Some time after this MPC installation was completed, the Process Analytical Technology, PAT, initiative was established by the Federal Drug Administration (FDA) to encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. As part of this framework, an innovative approach has been developed for helping the pharmaceutical industry address regulatory issues and questions. This new approach is discussed in Guidance for Industry, PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. Through this initiative, the pharmaceutical industry has been given an opportunity to more easily innovate and improve operations through the application of proven measurement and control techniques.