Aim: To demonstrate the potential of in-line nanoparticle size measurements using the NanoFlowSizer (NFS) as a PAT method. To achieve real-time process control by establishing automated regulation of ...

Control charts play a fundamental role in ensuring and improving the quality of manufacturing items. These charts consist of upper and lower limits, within which manufacturing operations should ...

Statistical Process Control (SPC) aims to achieve two primary objectives: first, it seeks to detect deviations in performance from the ideal state, and second, it aims to determine the underlying ...

Continuous manufacturing and a quality-by-design development approach are a natural fit. FDA, as well as other regulatory agencies around the world, have for many years been encouraging drug makers to ...