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Conventional pharmaceutical manufacturing generally uses batch processing with laboratory testing of sampling used to evaluate quality, and this approach "tests-in" quality.

Quality can be "built-in". In the US the FDA recognised that a huge opportunity to reduce the cost of pharmaceuticals to the public without any reduction in quality. They published the PAT Guidance to Industry in September 2004 to outline the regulatory framework when applying these novel techniques.

The engineers at 3P share the FDA's vision for the future of pharmaceutical engineering: a vision of continuous processes, real-time release, in-line sensors and above all a significant increase in process understanding. Through the use of scientific principles the level of process understanding will increase and the pharmaceutical industry will move up the knowledge pyramid.

  • Knowledge Management - Capturing current state of the art ("the knowledge space")
  • Process Mapping
  • Ranging studies to define the "Design Space"
  • Design of Experiments (Taguchi or partial factorial designs) to define the control space
  • Implementation of "PAT" sensors
  • Close loop control and derivation of "closed loop control space"

We also understand that the conversion of a laboratory sensor to a production environment is less than trivial. We implement "PAT" and/or "soft" sensors.

 
 

 

 

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