Experimental comparison tests of different systems for the validation of some parameters of standard and non-standard steam sterilization processes

The authors have devised a set of steam sterilization tests to investigate to what point the presence of air can alter not only the process, but also the correct control of an industrial sterilization cycle. In addition to the usual autoclave equipment, a control apparatus with special software has been employed. Then, by comparing the results obtained with biological and chemical indicators, F0 detectors with a standard software and with adapted software respectively, it has been possible to estimate how inaccurate some of the present validation methods are. With the data obtained from such test, some trend curves showing the real behaviour of the sterilization parameters have first been plotted, then the mathematical algorithms have been elaborated, allowing us to suggest a new approach for the validation and the management of a sterilization cycle.