It’s interesting how some technologies exist for many years before coming into the spotlight.  One such technology has now been labeled as “Process Analytical Technology”, or PAT.  This technology has been implemented for years, particularly by the chemical and consumer products industries.  Some of The LabMan’s graduate student colleagues were hired by Dow Chemical and Procter and Gamble in the early 1980’s to develop PAT tools, and The LabMan himself was doing PAT in a major pharma company in the ‘80’s, before robotics stole his attention.  Now, decades later PAT is in the spotlight thanks to the FDA, having become a cornerstone of the US Food and Drug Administration’s (US FDA) Quality by Design (QbD) initiative for both the design and control of quality processes. While PAT is most often associated the monitoring and control of manufacturing processes, it should be noted that PAT tools can be implemented in the laboratory focused more on the design of a quality process. 

PAT makes use of many of the tools and technologies as laboratory automation.  The analytical and detection tools have often been derived from laboratory instruments (such as chromatographic and spectrophotometric techniques) and the implementation of PAT has been greatly enhanced by the developments in microfluidics and biosensors.  Even more so than in the laboratory, with PAT, smaller instruments that consume less reagents are a major plus.  Software familiar to screeners, such as Design of Experiment (DOE) software and multivariate data acquisition and data analysis tools, is an essential part of PAT.   

Before the term PAT became into vogue, “process analytical chemistry” generally described the science and technology associated with displacement of laboratory based measurements with sensors and instrumentation positioned closer to the site of operation. Industrial process analyzers have been in use for more than 60 years, but       the modern period of PAC essentially began in the late ‘70’s and early ‘80’s.  In 1984, the Centre for Process Analytical Chemistry (CPAC) was established at the University of Washington to “supply quantitative and qualitative information about a chemical process”for monitoring, control, and optimization. The industrial PAC movement has benefited by two decades of advances in materials science, electronics, and chemo metrics. The pace of innovation in sensors, micro-scale instrumentation, and analytics has grown, often first implemented in a laboratory environment before being introduced to the process environment. The development of more robust, sensitive photo detector materials, micro electro mechanical systems (MEMS), and fiber optics and the never-ending advancement of computing power have both increased the performance and reduced the cost of PAC. As a result, PAC is now a critical part of routine operations within the realm of industrial chemistry.   

The point The LabMan would like to make is that laboratory automation and PAT are cousins in the technology world.  PAC/PAT evolved out of the need to do laboratory-type measurements closer to a real-time process, to provide more immediate information about the status of a given process.  At the same time, laboratory automation has turned many laboratory experiments into a “process” that requires a very similar “PAT-like” mindset toward measurement and control.  The two approaches come together in the realm of early-stage process scale-up, where laboratory meets pilot plant.  The practitioners of laboratory automation and PAT can and should learn from each other and the two communities should do more to arrange crossover learning opportunities.

Until Next Time,

Domo Arigato, Mr. Roboto