A complete PAT solution (as suggested by the Food and Drug Administration and accepted universally) is defined as: "The use of process analyzers operating in real-time to facilitate the acquisition of information useful and necessary to the understanding, follow-up and control of processes, ensuring the quality of intermediary products obtained from different unitary operations as well as of finished products, when these analyzers are used with one or more PAT tools."
In concrete terms, a complete PAT solution is the integration of knowledge and devices developed in multiple study projects proposed in the scope of this Chair to measure critical parameters, understand, monitor and control the different modules of a dry formulation of divided solids.The capacity to predict and, consequently, to control the behavior of a process needs high level understanding of the process.
"Understanding of the process" means that all critical sources that could cause system variability are identified and explained and that variability is controlled. Furthermore, it implies that predicting proper attributes with accuracy and confidence is possible for product quality when variation occurs at the level of the material used, the process parameters, environmental and other condition
A complete PAT solution is based on the use of analytical technologies (mainly on-line). Thus, the design and construction of equipment, analytical tools and their interfaces are critical to ensure that the acquired data are meaningful and representative of system attributes.
The implementation of a PAT solution requires many steps: after having chosen the manufacturing process, the main critical parameters of acquisition are defined, and the choice and execution of on-line and non-destructive techniques and analytical technologies are then approached through different applications. These techniques necessitate the building and validation of chemometric models to exploit the results.
Four major types of pharmaceutical processes could profit from the results obtained with PAT solutions: