What do we need from PAT?
Pharmaceutical manufacturing in the modern era is facing unprecedented demands, including in-depth scrutiny of production methodology, and inefficiencies in current practices with respect to waste, energy usage and time management. Coupling this with increased complexity in the manufacture of newer products and the decline of blockbuster drugs, results in an industry striving to drive down overhead costs and increase plant efficiency and capacity on a daily basis.
THE use of process analytical technology (PAT) is nothing new. In 2004 the US Food and Drug Administration (FDA) outlined the use of PAT, using the original definition: “PAT (is) a system for designing, analysing, and controlling manufacturing through timely measurements (ie, during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality”.1 This definition allows a broad scope to be taken when defining measurement/sensing technology and analysis techniques. Additionally, three process domains can be identified within the FDA’s vision: process development (design), process monitoring (analysing), and continuous optimisation/control (controlling). Since its introduction, PAT has proven useful for many process unit operations within both primary (API) and secondary (final dosage form) manufacturing.2,3