Abstract
Sterile medical devices provide critical care and diagnostic applications where sterility is validated by
demonstrating the inactivation of reference Biological Indicators (BIs). However, BI’s are qualified using
conventional culture-based methods that may limit the ability to fully appreciate the bacterial inactivation
kinetics of a sterilization process such as vaporized hydrogen peroxide (VH2O2). This timely study reports on
potential for use of flow cytometry (FCM) as a real-time enumeration technique that overcomes such
limitations. It also provides novel insights into killing kinetics to support and advance sterilization processes.