You have a sterility or Bioburden test failure

This presentation will review the various items that should be investigated to determine the root cause when a failure occurs during a sterility test for biological indicators

During validation or routine processing for EO sterilization processes.
During a test of sterility following a verification dose either initially or during a dose audit.
When the product bioburden level exceeds the alert or action levels that have been established for the product.
It will also cover the actions to be taken as a follow up to the investigation.