Environmental monitoring is performed to meet the requirements of quality system regulation when such an environment can influence the pre-sterilization bioburden level or resistance on a medical device.
Our medical device consulting experts will make sure that you are conducting an appropriate amount of sampling to suit your environmental monitoring needs. We can provide you with a protocol, track your data, and document results that will be the underlying support of your entire sterility assurance program.
Common Assignments
- Viable air sampling
- Airborne particle counts
- Water testing
- Bioburden
- Microbial identification
- Surface sampling
- Personnel monitoring
- Data handling and analysis