Process analysis technology permeates every aspect of pharmaceutical production — Improved process understanding, higher process reliability, and fewer rejects: PAT techniques can achieve all this and more.
A lot has changed since America’s FDA decided to incorporate more process analysis technology into pharmaceutical production back in 2003. The objective of the PAT initiative has not changed, however: Still today, it aims to optimize the production of pharmaceuticals and improve process understanding.
Over this time, the market has seen the introduction of a wide range of technologies and sensors suitable for such applications. In general, the FDA initiative does not make any distinction between types of instrumentation provided that its output can be used to draw conclusions about critical process parameters and quality attributes.
In this respect, the limits between process analysis technology and “normal” measurement technology are completely fluid. In many cases, even a simple product temperature measurement system in a granulation process may operate in accordance with PAT criteria.
More elaborate optical procedures such as Raman or NIR are well-known techniques in the production of pharmaceuticals; however, complex systems of this kind are seeing relatively slow acceptance into routine use in production. This is because implementation, method development, and validation are very expensive, and it is this cost that is deterring many production managers from investing in PAT solutions.
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