Sterilization Monitoring

A biological indicator provides information on whether necessary conditions were met to kill a
specified number of microorganisms for a given sterilization process, providing a level of confidence
in the process. Endospores, or bacterial spores, are the microorganisms primarily used in BIs.
A biological indicator is made up of a carrier material, on which bacterial spores with a defined
resistance to the sterilization process have been applied. The carrier material is enclosed within a
glassine vial. The BI is exposed to the sterilization process and then incubated under defined growth
conditions to determine whether any spores survived the process. If no spores survive, none grow
and the test is a pass. If growth is detected, the test is a fail.