The FDA’s PAT (Process Analytical Technology) initiative has enabled GEA Pharma Systems to combine its equipment design skills and process engineering know-how in order to integrate online (PAT) analysers into its process systems in a way which can provide real insight into the operation of the process and help customers achieve key product quality target .
The goal of the PAT initiative is to ensure that pharmaceutical products are manufactured using processes which are understood and monitored so that the key quality characteristics of the
products can be actively controlled.
Combining process monitoring using online analysers, together with solid process engineering principles and advanced process modelling techniques will enable processes to be actively
controlled in order to compensate for minor input variations (eg. raw materials) so that the specifications for the final product will be closer to the ideal target.
Using process models to identify the process conditions that highlite products which perform best in subsequent processes will enable the whole production process to be targeted towards the performance of the final dose rather than just optimising each unit operation individually. GEA Pharma Systems wide scope gives it a unique perspective on the complete process.