A Spanish Inter-laboratory Comparison on the Characterization of Sterilization Autoclaves

Abstract

Sterilization autoclaves are devices used to sterilize equipment and supplies; their users require a periodic determination of their performance to ensure that the required temperature is reached and maintained for the predefined time interval. Within the ENAC (Entidad Nacional de Acreditacion, Spanish national accreditation body) Temperature and Humidity Technical Subcommittee, it was decided to carry out an inter-laboratory comparison on the characterization of sterilization autoclaves aiming to demonstrate the equivalence among the test procedures of the different participants. This paper presents the data processing and the results of this comparison that showed some discrepancies in the stability and uniformity measurements due to different parameter definitions and a probable underestimation of some uncertainty sources. The results show good agreement among the participants in the estimation of the set-point correction, while the estimation of the device stability and uniformity was not compatible in some cases. The use of wired or wireless sensors did not bias the results, but the laboratories that used pt-100 obtained results that underestimated the value of the thermal stability, probably due to their higher thermal mass and response time.