作　　者： ; (易禄荣）; (周于胜）; (冯雨艳）; (唐琳）;

机构地区： 四川大学

出　　处： 《工业技术创新》 2016年第1期38-42,共5页

摘　　要： 检查并确认灭菌柜的运行和性能是否符合要求,查看空载情况下灭菌柜不同位置的热分布状况,确定灭菌过程中冷点的位置,设定灭菌程序的有关参数,用试验来证实灭菌运行的可靠性及灭菌程序的重现性,以确保灭菌后产品的污染率低于10^(-6)。本文分析了空气泄漏试验、B-D测试、空载热分布、负载热穿透、生物挑战性试验等方法。得到的试验结果均符合要求,芽孢灭活试验结果均为阴性。 To check and confirm the performance of sterilization cabinet confirmed to meet the requirements, the view under the condition of no load sterilization cabinet in different position of heat distribution and determine the position of the sterilization process cold and set the relevant parameters of the sterilization process, test to confirm the reproducibility of the sterilization operation reliability and sterilization procedures, to ensure that the sterilized product contamination rate of less than 10^(-6). Methods: air leak test, B-D test, no-load heat distribution, load heat penetration, biological challenge test method. Results: all the test results were in accordance with the requirements, and the inactivation test results were negative. Conclusion: the performance indexes of steam sterilization cabinet meet the production requirements, can be put into production and use, and thus establish a set of suitable for the company's steam sterilization cabinet performance validation method.

关 键 词： 蒸汽灭菌柜 性能验证 空气呼吸器灭菌效果确认 空气泄漏试验 测试 空载热分布 负载热穿透 生物挑战性试验

领　　域： [化学工程]