Process Analytical Technology (PAT)
A PAT initiative can require the purchase of new instruments that can make additional real-time measurements during production. In many cases, those instruments measure the Critical Process Parameters (CPP's) and Critical Quality Attributes (CQA's) in real-time.
The value of any PAT or process improvement initiative depends on a sufficient understanding of all the prior process data, analysis of which is used to build a model of the relationships between CPP's and CQA's which can be used for real-time process control. This in turn depends on end users using Aegis' Discoverant for easy access to all the relevant process data on-demand in an environment with integrated analytical capabilities.
When the relationships between CPP's and CQA's are sufficiently understood, it may be desirable to adjust process control systems in real-time by interfacing them directly with process models derived from examination of process development and/or manufacturing process data. This is consistent with the real-time quality assurance goals of Quality by Design that a PAT approach can offer. Such models are generally the best models to use for control of full-scale operations because the effects of scale have been accounted for (since they were derived using full-scale data).