Review of surface steam sterilization for validation purposes.
Sterilization is an essential step in the process of producing sterile medical devices. To guarantee sterility, the process of sterilization must be validated. Because there is no direct way to measure sterility, the techniques applied to validate the sterilization process are based on statistical principles. Steam sterilization is the most frequently applied sterilization method worldwide and can be validated either by indicators (chemical or biological) or physical measurements. The steam sterilization conditions are described in the literature. Starting from these conditions, criteria for the validation of steam sterilization are derived and can be described in terms of physical parameters. Physical validation of steam sterilization appears to be an adequate and efficient validation method that could be considered as an alternative for indicator validation. Moreover, physical validation can be used for effective troubleshooting in steam sterilizing processes.
van Doornmalen
Joost
J
Department of Validation and Monitoring, Bureau Veritas, Amersfoort, The Netherlands.
Kopinga
Klaas
K
D004864:Equipment and Supplies; D007202:Indicators and Reagents; D011786:Quality Control; D013227:Steam; D013242:Sterilization / Q000379:methods* / Q000592:standards*
D007202:Indicators and Reagents; D013227:Steam