Process Analytical Technology (PAT)

Process analytical technology (PAT) is a landmark in the acceptance of process systems engineering tools in modern bio and pharmaceutical manufacturing. PAT is defined as "systems for analysis & control of manufacturing processes based on timely measurements of critical quality parameters and performance attributes of raw-materials and in-process products, to assure acceptable end-product quality at the completion of the process" (i.e., quality by design).

By using DOE and Multivariate Process Analytical Chemistry and Multivariate modeling and supervision of each unit operation or process stage in a complex process, an overall quantitative picture emerges of the entire production line.

As an overall picture emerges of the entire multistage process, based on a more accurate picture of its constitutive unit operations, integration of this distributed knowledge into a plant or process-wide perspective is of significant value in the PAT context. In fact, this can enable the anticipation and solving of problems that may have a negative impact downstream (e.g. accepting or rejecting a certain raw material lot).

At 4Tune we know how to make a successful project in PAT to deliver on expectations and obtain the computed ROI.

The potential of Process Analytical Technology (PAT) in manufacturing is far from properly exploited mainly due to the insufficient use of intrinsically multiparametric monitoring tools (e.g. techniques that can measure several sample attributes or do its fingerprint), ineffective use of available process information (e.g. data on historical batches and data collected at different process stages such as raw material lots), and little exploitation of a process/plant wide perspective for the proposed PAT strategy.

Once a new technology rolls over you, if you're not part of the steamroller, you're part of the road.”

Stewart Brand