Unleashing the Potential of PAT with Real Time Knowledge Management and Quality Based Control
Martin Gadsby: Director of Optimal Industrial Automation Ltd Bristol, UK
After many years of being a technology used solely by researchers and industrial evangelists, PAT is finally making a very real and exponentially growing impact on the manufacture of pharmaceuticals as more and more companies realise that you truly can have improved product quality whilst at the same time achieving a reduction in cost and manufacturing time. Furthermore, the holistic approach embraced by PAT is having a growing impact on manufacturing in the food and chemical industries to name just two, where the perhaps occasional use of unconnected and ‘uncontrolled’ spectral instruments have been used for many years.
The application of PAT is a team effort where multiple skills, disciplines and technologies are required, and a technical keystone to a cost effective and regulatory compliant deployment is the central ‘hub in the wheel’, the PAT Knowledge Manager such as synTQ. This software package is used to tie together and coordinate in real time multiple multivariate and univariate data sources and consumers and facilitate the generation of quality predictions. Furthermore, a key point of PAT is process understanding, and you need a system that can turn data into information and then in turn to knowledge, this being disseminated to the users in a fashion that is digestible and usable. Process control is required – both feed forward and feedback, and you need a system that is regulatory compliant and is a fundamental tool in the continuous improvement programme that is such an essential part of maximising the PAT benefits.
Finally, you need a system that is scalable and usable from the laboratory to full GMP manufacturing, and can be used on discrete, batch and continuous processes.
This presentation sets out to describe in more detail some of the technical data management challenges that will be encountered on a PAT deployment journey, and possible technical and product solutions that are available for you to add to your PAT ‘armoury’.