(509g) PAT Data Management for Continuous Manufacturing – the Next Generation

Authors: 
Docherty, P., Siemens
Francois, K., Siemens

The mind shift from batch production to continuous manufacturing has been made in the pharmaceutical industry for a couple of years, but the IT infrastructure to cover the analyzer integration, data management and advanced process control was put under pressure by this new paradigm. The current generations of PAT data management platforms are bridging the gap when it comes to full robust and reliable integration of analyzers, high throughput dataflows, and a further and deeper integration in the process automation layer.

Also optimized time alignment is critical to combine the right pieces of information. In this presentation we will dig a bit deeper in time alignment applied on hot melt extrusion lines with dynamic line speeds, and how this can be translated into optimized time alignment. Automated selection of PAT data collection methodology with specific time alignment settings will be discussed based on actual process parameters and decision trees.  This will show the importance of a very close integration between the automation layer and the PAT data management on top. And we will go even a step further…

Also the user interface is an important aspect in smoothening the integration of PAT data management into continuous manufacturing. UX or user experience is the new trend to optimize the user interfaces for your operators into the IT platforms. Logic user-focused workflows are guiding the operator though the different necessary steps of operation. Some examples from the new SIPAT 4.1 operator dashboard will be shown after it was revamped by a team of UX specialists.

A last item to be discussed is data security. The IT landscape is more and more the backbone of all the decisions taken on the quality of your products. This makes your network a vulnerable source for hacking, sabotage and potential terrorism. In how far are you aware that data from your analyzers could be captured on the fly and slightly changed, so the wrong decisions are made in the end? Man-in-the-middle attacks have caused serious issues in the past and should be avoided at all times. We have gone that additional step by offering data solutions, fully ensuring and securing your data security.