Design elements include:
- Assess design from the perspective of determining bioburden limits
- Assess design from the user’s perspective in terms of product use
- Evaluate cleaning on design considerations for devices intended for re-use
Process elements include:
- Defining process limits related to design and use requirements
- Developing validation protocols to assess process cleaning and disinfection
- Characterizing particulate and environmental bioburden
- Developing statistically-based environmental programs related to design and process requirements