This paper reviews the issues that isolator users need to be aware of prior to specifying and using a biological indicator for their decontamination cycle validation studies.
A great deal of information is available in the literature on the relative resistance of microorganisms to aqueous hydrogen peroxide (H202); however, the same cannot be said for H202 in the gaseous state. Bacillus stearothermophilus spores were found to be the most resistant to the sterilant and the presence of organic soil did not affect the ability of H202 gas to sterilize stainless surfaces.
This paper covers the factors that can affect a D-value and it discusses the equipment and methods that have been used to satisfactorily estimate it within isolator applications.
