By Jake Newberger (Jacob Newberger)
Jacob Newberger – A mechanical engineer with specialties in robotics and automatic control systems,
Process Analytical Technology (PAT) is quickly becoming an integral component in the pharmaceutical and chemical manufacturing industries. Utilizing a low latency network of powerful chemometric instruments, multivariate data analysis software, process control tools, and a central SQL database, PAT provides pharmaceutical and biopharmaceutical companies an edge over their competitors.
PAT and its benefits are incredible and groundbreaking. Done are they days of a rigid manufacturing line and discarded low-quality batches due to the unforeseen consequences of factory automation “improvements”. Instead, PAT is a flexible system capable of keeping pace with the rapid advances in drug development and manufacture. At the core of any PAT system are a set of Critical Process Parameters (CPPs) that are defined based on the manufacturing equipment itself, and those CPPs will function as the independent variables along the production line. By monitoring physical and chemical properties, the manufacturer can also define a set of variable CPP-dependent variables known as Critical Quality Attributes (CQAs) at various stages of the process, allowing the manufacturer to better understand and control the entire process. These CPPs and CQAs are then used in conjunction with a PAT platform to create both unit-level and high-level process line models capable of predicting the precise quality of the end product. After the predictions are made, adjustments can be made and be fed back into integrated control systems such as Siemens SIMATIC PCS7, fine tuning the manufacturing process to further improve product quality and ensure product consistency.
PAT platforms have been developed by automation industry leaders such as Siemens, and current PAT solutions are supported by a vast number of major analyzer manufacturers such as Mettler Toledo, Thermo Scientific, Kaiser Optical Systems, and the Bruker corporation. The Siemens implementation (SIPAT) is configured to work with these manufacturers by default, however SIPAT will integrate with nearly any analyzer, including those capable of NIR spectroscopy, NMR spectroscopy, or FBRM.
Non-destructive on-line or at-line testing of the product allows the manufacturer to achieve Real Time Release Testing (RTRT) that has been specifically cited by the FDA to increase economic benefit and manufacturing efficiency by lowering laboratory costs and reducing inventory. An FDA white paper from 2004 delves deeper into the benefits of, and can be found at http://www.fda.gov/downloads/Drugs/Guidances/ucm070305.pdf
As modern medicine continues to advance at breakneck speed, the technology used to scale up and manufacture those advances will have to keep pace. PAT is not just evolutionary, but truly revolutionary, analogous to the advent of batch processing twenty years ago, which has now become the industry standard.
A graduate of Penn State’s top-ranked mechanical engineering program, Jake Newberger (Jacob Newberger) is an Automation Engineer at Panacea Technologies, Inc., located outside of Philadephia.