Process analytical technology technologies

Bakeev, K.A. Process Analytical Technology, Blackwell Publishing, 2005. 

Chemometrics became well established in chemical industry within process analytical technology, and is important in the fast growing area of biotechnology. 

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. 

Process Analytical Technology 2e Edited by Katherine Bakeev 2010 John Wiley Sons, Ltd. 

Process Analytical Technology 1.5 Glossary of Acronyms and Terms... 

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... 

With the onset of the QbD initiative (see Section 2.3.4), first codified in the ICH Q8 document in 2006, the above-mentioned broader definition of process analytical technology has somewhat evolved into parts of the key elements of the broad definition of QbD, resulting in a partial retraction of the term PAT back... 

Implementation of Process Analytical Technologies 21 Table 2.1 Differences in process analytics applications in R D and manufacturing... 

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