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
