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