实验用物料湿热灭菌实践与改进建议  

Practice and improvement suggestions on moist heat sterilization of experimental materials

作　　者：忻运 魏佳鸣 XIN Yun;WEI Jiaming(Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203,China)

机构地区：[1]上海市食品药品包装材料测试所,上海201203

出　　处：《上海医药》2023年第17期74-80,共7页Shanghai Medical & Pharmaceutical Journal

摘　　要：目的:通过对实验室内一台湿热灭菌器性能验证,优化湿热灭菌验证工艺并提出可操作性的建议。方法:利用无线测温仪监测灭菌器腔体温度均匀度、温度波动度、灭菌时间、最小等效灭菌时间(F_(0))和生物指示剂等信息,分析灭菌效果。结果:经30次验证的实验结果均符合灭菌验证可接受标准。结论:所有数据可以得出连续、重现、一致的验证结果,证明该灭菌器具备良好的灭菌性能且可以投入使用。建议重点关注冷点分析、最难装载、D值与初始污染菌研究,以保证灭菌工艺处于受控状态。Objective:To optimize validation process of moist heat sterilization and propose feasible suggestions by verifying the performance of a moist heat sterilizer in a laboratory.Methods:The chamber temperature uniformity and temperature fluctuation in the sterilizer,sterilization time,minimum equivalent sterilization time(F_(0))and biological indicator were monitored by wireless thermometer and the sterilization effect was analyzed.Results:The experimental results were in line with the acceptable standards for sterilization validation after 30 times of validation.Conclusion:Continuous,reproducible and consistent verification results can be obtained from all the data,which prove that the sterilizer has good sterilization performance and can be put into use.It is suggested to focus on the cold point analysis,the most difficult loading and the study of D-value and the initial contaminating bacteria to ensure that the sterilization process is in a controlled state.

关 键 词：湿热灭菌 压力蒸汽灭菌器 验证 无线温度测试仪 

分 类 号：TQ460.5[化学工程—制药化工]