Process Analytical Technology

PAT is a technology that enables you to understand your process by providing you with PRODUCT data in real time as opposed to PROCESS data.  Traditionally when a process is run you will monitor and control process parameters such as temperature, pressure, speeds, flow rates etc., however whilst these obviously have an effect on your process you are normally not measuring many (if any) product parameters until the end of the process – when it is too late.  The process is run to a pre-determined manufacturing profile with the assumption that the product – and specifically the Critical to Quality product parameters are as required at the end of the process.  These are only verified at the end of the process by your QC lab.  Very often what is going on within the process is not fully understood, and operations are taken simply because empirical experience has shown that by taking a certain action the end result is usually OK.  Add to this the natural variability of raw materials and you have the situation where the output product quality is varying much more than it needs to.  With correctly applied PAT your Critical to Quality parameters can be measured in real time, and by using the process understanding knowledge gained through the use of PAT the process input parameters can be adjusted so as to optimise your product’s quality.  Wastage can be significantly reduced as can the overall production time not to mention the ultimate goal of real time release.

Optimal has been a world leader in PAT (Process Analytical Technologies) for many years, our appointment to be part of the FDA Auditors training team for PAT underlining our recognition in the marketplace.  Our product synTQ® provides a world leading PAT Data Management System that can be deployed from a very cost effective single instrument level through to fully supported global applications.