Can there be metrics in the process that can accurately predict the quality of the end product? Is there a regulatory framework for it? Can it be scientific? Will it encompass all aspects of continuous manufacturing especially in the areas of pharmaceuticals and bio-technology that have a direct impact on the wellbeing of people?
An emerging area of regulatory framework for the comprehensive analysis and control of the overall manufacturing process based on key quality parameter measurements and various attributes of inputs, work-in-process with an intent to be able to predict the quality of the end product can be defined as the process analytical technology (PAT). PAT comprises of many aspects of “chemical, physical, microbiological, mathematical, and risk analysis” of a continuous manufacturing operation more specifically in the area of pharmaceutical or biochemical manufacturing process.
The fundamental philosophy of PAT is to build quality control into the process itself in an effort to be able to have a complete control of the process in general. PAT tools can be used in combination or isolation. PAT can be used to club chemometric tools and process analysers where required. Implementation of PAT has a few advantages because of the tight control it exercises on the process. IT can completely assure the end product quality. The measurements in a PAT environment can be at-line, on-line or in-line. A variety of process monitoring techniques like near infrared, Process Raman Spectroscopy, Fourier Transform infrared Spectroscopy, Online UV-Vis Analysis, Chemical imaging, Process Mass Spectroscopy, Laser-Induced Breakdown Spectroscopy etc., can be used.
Chemometrics with PAT tools can actually reduce and prevent out-of-specifications, reprocessing and rejects in the manufacturing line. Thereby making become PAT tools with chemometrics powerful tools in real-time monitoring of manufacture.
Bibliography
Potumarthi, S. C. &. R., 2013. Chemometrics-Based Process Analytical Technology (PAT) tools: Applications and Adpatations in pharmaceutical and biopharmaceutical Industries. Applied Biochemical Technology, Volume 169, pp. 66-76.
Source in the pdf file for management accounting:
- Page 67, paragraph 1, point [1]
- Goal of PAT is (3) in 1 above.
