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Increase profit with process analytical technology eoswiss engineering slideshare

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Use Process Analytical Technology PAT and Quality by Design QbD to speed up development, improve quality and increase profits.

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Increase profit with process analytical technology eoswiss engineering slideshare

  1. 1. EOSWISS Engineering Sàrl Innovation - Process Excellence - Business Development Increase Profits With Process Analytical Technologies EPHJ - SMT - 2015 «Innovation and Process Excellence» Conference Genève 3. June 2015 Dr.Georg Astl
  2. 2. 1. Legal Requirements • FDA 2. Quality by Design • Efficient Development • Lower costs at Registration 3. Process Analytical Technology • Higher Profits through better quality Summary 2
  3. 3. 3 “a system for designing, analyzing and controlling manufacturing through timely measurements (i.e. during processing) of critical quality and performance attributes of raw and inprocess materials and processes, with the goal of ensuring final product quality” FDA, 2004 FDA
  4. 4. 4 Quality by Design Systematic variation of relative concentration of Component A and pressure (= B) Pressure B Relative concentration component A The most efficient lay out!
  5. 5. 5 Quality by Design Design Space can be used for registration. Process variation inside the design space – NO Process Change Large Cost advantage during the years of production
  6. 6. 6 Process Analytical Technology 12 online sensor example Classic Situation Sensor Output Totally 12 Sensors Is it OK ???
  7. 7. 7 Process Analytical Technology Multivariate Analysis – Principal Component Visualization 2 Dimensions. Process instabilities corrected immediately. No claims! No costs! Instability in the process is seen easily!
  8. 8. 8 Process Analytical Technology Multivariate Analysis – Principal Component Visualization 3 Dimensions On - line Process Control : Instability is corrected immediately! No claim! No Cost!
  9. 9. 9 0 20 40 60 80 100 120 Turn over and profit Re-work and claims Turn over and profit Profit Claims Turn over + 10 % increase in profit 1% of re- work and claims = 10% of profit Process Analytical Technology
  10. 10. 10 • FDA requires Process Analytical Technology • “Quality by Design” = Cost reduction at Registration stage • Process Analytical Technology: Improve profit through better quality! Summary

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