Medical device manufacturing is complex convergence of electronics, chemical and pharmaceutical technologies. This is exemplified by the increasing prevalence of new devices which also contain active pharmaceutical ingredients and excipients.
Medical device manufacturers must now:
- Understand and control the potential interactions among the active pharmaceutical ingredients, chemicals and electronic components
- Account for complex batch/lot genealogies in support of serialization
- Improve the performance of their manufacturing processes using OEE measures
- Control sources of variability within their processes