Pharmaceutical Technology-11-01-2006

Large amounts of data are currently being generated in an attempt to understand and improve formulation, process, and manufacturing efficiency. This task requires novel data mining software systems tailored specifically for the formulator and process engineer.

This article examines what other industries have done to address the challenges associated with successfully implementing the principles and concepts of process analytical technology, particularly the specific elements of measurement, analysis, and control. The author explores how other industries' approaches can be applied directly to pharmaceutical manufacturing.

This article discusses the role of process simulation and scheduling tools in the development and manufacture of pharmaceutical products.

Modeling conducted in the process development and early commercialization stages can increase process efficiency and lead to process-control improvement. A virtual plant environment, running on a PC, can incorporate the same industrial control systems and configuration expertise used in manufacturing and helps many parts of process analytical technology. It also can make possible the enlightened use of technologies such as model predictive control, first-principal models, neural networks, and multivariate statistical process control.