脉动真空灭菌器灭菌效果验证  

Validation of Sterilization Effect of Pulsant Vacuum Sterilizer

作　　者：牛振东 路银环 刘文杰 陈卓 井良义 NIU Zhendong;LU Yinhuan;LIU Wenjie;CHEN Zhuo;JING Liangyi(Beijing Institute Drug Control·Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing,China 102206)

机构地区：[1]北京市药品检验研究院·中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国药业》2022年第22期75-77,共3页China Pharmaceuticals

摘　　要：目的验证脉动真空灭菌器的灭菌效果。方法选择含嗜热脂肪地芽孢杆菌Geobacillus stearothermophilus的芽孢及培养基的压力蒸汽灭菌生物指示剂(BI)进行生物指示剂挑战试验,灭菌器1,2号锅上下层分别布置9个监测点。试验分为试验组、阳性对照组、阴性对照组。试验组BI经121.0℃灭菌15 min,置换6 min后释放芽孢杆菌,于56℃培养48 h;阳性对照组芽孢杆菌于56℃培养48 h;阴性对照组仅有培养基,于56℃培养48 h;检测灭菌效果。并以B-D测试法进行对照。结果生物指示剂挑战试验中,试验组(灭菌器1,2号锅各点位)及阴性对照组灭菌前后均呈紫红色、澄清状,阳性对照组呈黄色、混浊状;B-D测试结果显示试纸由黄色转为黑色。结论生物指示剂挑战试验适用于检查脉动真空灭菌器的灭菌效果。Objective To verify the sterilization effect of pulsant vacuum sterilizer.Methods The spores containing Geobacillus stearothermophilus and the pressure steam biological indicator(BI)of the culture medium were selected for the bioindicator challenge test.The upper and lower layers of sterilizer 1 and 2 pots were respectively arranged with nine monitoring points.The test group,positive control group and negative control group were set in this test.In the test group,BI was sterilized at 121.0℃for 15 min,the bacillus was released after 6 min of replacement,and the BI was cultured at 56℃for 48 h.In the positive control group,Geobacillus stearothermophilus was cultured at 56℃for 48 h.In the negative control group,there was only a culture medium,which was incubated at 56℃for 48 h.The sterilization effect was tested,and the B-D test method was used for comparison.Results In the biological indicator challenge test,the test groups at each point of sterilizer 1 and 2 pots and the negative control group were purple-red and clear before and after sterilization,while the positive control group was yellow and turbid.B-D test method showed that the test paper turned from yellow to black.Conclusion Biological indicator challenge test and B-D test are suitable for checking the sterilization effect of pulsant vacuum sterilizer.

关 键 词：脉动真空灭菌器 高压灭菌 生物指示剂挑战试验 B-D测试法 

分 类 号：R953[医药卫生—药学] R187