Putting Science to Work

Process Characterization Studies

Our process development team can also offer process characterization studies, that  include establishment and qualification of scale-down models followed by establishment of limits/ranges and technical and quality auditing of established processes.

Characterization studies involve:
  • Risk analysis to identify parameters to be studied
  • Characterization master plans and protocols
  • Qualification of scaled down models
  • Screening studies for individual parameters and parameter interactions
  • Process redundancy, impurity clearance, hold times, resin life studies
  • Worst case studies
  • Characterization reports

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