Process Analytical Technologies PAT

The chemometric basic tools may be divided into the following typologies of study data exploration, modelling, prediction and validation, design of experiments (DOE), process analytical technology (PAT), quantitative structure-activity relationship (QSAR). Details and relevant literature are reported in the following paragraphs. 

A chemical process is a series of steps. Each steps may be a chemical synthesis or a chemical analysis. Each step is multivariate. Hence, the global evaluation of the process must be a multivariate study process analytical technology (PAT) is applied. 

The FDA also introduces the concept of process analytical technology (PAT). PAT refers to systems that are used to analyze, monitor, and control manufacturing processes on a continuous basis. The quality attributes and specifications of raw materials, in-process intermediates, and processes are measured in real time and compared with predetermined parameters so that deviations can be rectified in a proactive nature to assure that the end products conform to the level of quality as expected. It is believed that a system based on PAT being implemented in a real-time manner would improve manufacturing efficiency and simultaneously retain or improve the product quality through these interactive measurements and controls. 

Discuss the benefits or otherwise of process analytical technology (PAT). 

CE instrumentation is quite simple (see Chapter 3). A core instrument utilizes a high-voltage power supply (capable of voltages in excess of 30,000 V), capillaries (approximately 25—lOOpm I.D.), buffers to complete the circuit (e.g., citrate, phosphate, or acetate), and a detector (e.g., UV-visible). CE provides simplicity of method development, reliability, speed, and versatility. It is a valuable technique because it can separate compounds that have traditionally been difficult to handle by HPLC. Furthermore, it can be automated for quantitative analysis. CE can play an important role in process analytical technology (PAT). For example, an on-line CE system can completely automate the sampling, sample preparation, and analysis of proteins or other species that can be separated by CE. 

FDA [Online], Office of Pharmaceutical Science (OPS) Process Analytical Technology (PAT) Initiative, Available http //www.fda.gOv/AboutFDA/CentersOffices/CDER/ucm088828.htm, accessed 7 December 2008... 

Introduction to Implementation of Process Analytical Technologies (PAT) in the Industrial Setting... 

Chemometrics in Process Analytical Technology (PAT) 393 Table 12.8 Summary of the polyurethane rigid foam samples used to illustrate various classification methods... 

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