高温蒸汽灭菌设备的验证方法与程序分析

Validating Methods and Procedure Analysis of High Temperature Moist Sterilizer

目的论述高温蒸汽灭菌设备验证方法和物理验证的重要作用。方法根据相关的灭菌标准对高温蒸汽灭菌过程进行温度检测,比较化学检测、生物检测与物理检测的异同,描绘出灭菌过程的温度曲线。结果与结论高温蒸汽灭菌设备的验证应采用测量温度、压力等物理验证方法,以保证灭菌过程和结果的可靠性,确保质量管理和设备的有效监控。

Objective To discuss the investigati important role of physical validation. Methods The tests according to relevant sterilization standards, testing and physical and chemical methods. We desc on on validating methods of moist sterilizer and the validation has been implemented with thermometric and provided difference comparing with biological ribed the process of sterilization by temperature-time relationship curve. Results and Conclusion Physical methods including temperature and pressure measurement should be used during validation of moist sterilizers, in order to assure the reliability of the steriliging process and result and ensure quality management and effectine monitoring of equipment.