Effect of carrier materials on the resistance of spores of XXXX to gaseous hydrogen peroxide.

@entity274 @entity8220
The testing of the @entity274 decontamination process using spores of @entity8220 has gained widespread acceptance. Usually, commercially available Biological Indicators (BIs) with a specified resistance to @entity274 are challenged to qualify the process. The question arises whether the resistance of test spores is dependant on the type of carrier material and whether the resistance is representative for the system under test. The objective of the study is to quantify the effect of different carrier materials on the resistance of spores of @entity8220 to @entity274 . Materials from which isolators were built, as well as those used in disposables during daily work were investigated. These materials were inoculated with 106 spores of @entity8220 (ATCC 7953). The spore resistance was tested to a well defined @entity274 decontamination cycle by determining the D-value using the "Fractional Negative" method. This paper reports on the effect of different carrier materials to the resistance of the test organism against @entity274 . Various materials have significantly increased resistance of the spores and should be avoided in isolator systems. If commercially available BIs are used for process qualification, the resistance of the BI used, the fluctuation in resistance caused by isolator materials, the required log reduction, and at least the bioload of isolator surfaces need to be known.
