Validation of the Physical Process of Steam Sterilization: Experience Report
Keywords:
validation, steam sterilization.Abstract
Validation of the sterilization cydes by steam is a legal demand of ISO/NBR 11134, seeking to assure the quality of the material sterilized under steam autoclavation. lt was developed a study in a central supply unit located in a hospita l of extra size in the city of Santos (BR) to describe the validation process of a steam sterilizer after the changing of the inner cham ber. ln this central supply unit the steam is provided by two different sources and then it was compared the outcomes of the validation process by using steam from a pipe-line with those obtained from the use of steam provided by a generator. Oualification of the functionality of the equipmen t showed that the appropriate tem pe ratu res were reached. ln the qualification with steam from a pipe-line was observed two poi nts w i th temperatu res va rying of 0,3 to O, 7ºC of the reference tempera tu re, however this variat ion was of up to 11ºC below reference temperature with the steam generated by esterilizador. After ana lyzing possible causes it was detected a problem in the gasket after the changing of the inner chamber. The validat ion in two ways of steam supply reveled a problem that could have been masked, i n case the qualification was not accomplished with both steam sources The popularization of this report is pertinent as track for resolution of problems when similar problems happen in the validation of autoclaves
References
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