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Process Analytical Techonology and QbD


Currently the FDA and other regulatory agencies encourage the pharmaceutical industry to use process analytical technologies (PAT) and Quality by Design (QbD). This will support a shift in manufacturing from validated pharmaceutical production towards science based, well characterized processes, which are deeply understood. Apart from better process understanding potential benefits of PAT include batch to batch reproducibility, fewer batch failures and rejection rates, cycle time reduction. One key enabler for better manufacturing is the use of innovative in-line and on-line analytics for process control.

The CPES has infrastructure and special expertise in the area of in-line process monitoring of pharmaceutical extrusion and other processes utilizing:

We also provide expertise in the area of in-line monitoring of crystallisation processes using:

  • Real Time Microscopy

Real-time microscopy allows direct observation of particles, crystals and droplets as they occur during the process. By doing this we can better understand the process and provide real-time supporting evidence for process optimisation.

  • Focused Beam Reflectance Measurement (FBRM)

Process Analytical Technology and QbD 2.

Focused Beam Reflectance Measurement (FBRM®) allows us to measure particles and droplets (particle dimension and relative particle count) in concentrated suspensions and emulsions in real-time without sampling.