一种医用消毒擦片的辐照灭菌剂量确定

DOSE CONFIRMATION OF IRRADIATION STERILIZATION APPLICATION FOR A KIND OF MEDIUM ISOPROPYL ALCOHOL SWAB

根据ISO11137-2:2006方法一、ISO11737-1:1995、ISO11737-2:1998,采用薄膜过滤法系统研究了一种医用消毒擦片的辐照灭菌剂量,内容包括初始污染菌数测定、验证剂量(无菌保证水平为10-2所要求的剂量)辐照、辐照后产品无菌检验等。结果表明,医用消毒擦片具有较强的抑菌活性,稀释液用量为400ml/片时抑菌活性可被消除。本试验条件下,医用消毒擦片的平均初始污染菌数为5.36CFU/片,查对ISO11137-2:2006表5得到验证剂量为4.6kGy,无菌剂量为16.8kGy(无菌保证水平为10-6所要求的剂量)。消毒擦片经验证剂量4.6kGy辐照后,100件单元产品的无菌检验的阳性个数小于2,达到ISO11137-2:2006要求,无菌剂量16.8kGy成立。研究还根据中国药典(2005)规定,对所建立的初始污染菌数测定方法和无菌检验方法进行了可行性验证。结果表明,无菌消毒擦片接种枯草芽孢杆菌、金黄色葡萄球菌、大肠杆菌后,利用初始污染菌数测定方法检测到的回收率均高于70%,初始污染菌数测定方法可行;接种枯草芽孢杆菌、金黄色葡萄球菌、铜绿假单孢菌、生孢梭菌、白色念珠菌、黑曲霉后,利用无菌检验方法均检测到良好微生物生长,无菌检验方法可行。

According to ISO11137-2 ： 2006 method one, ISO11737 - 1 ; 1995, ISO11737 - 2 ： 1998, Chinese Pharmacopoeia （2005）, dose of irradiation sterilization for a kind of medium isopropyl alcohol swab was studied. The experiments included microbial limit determination, irradiation close verification, sterility test and method validation. Results showed that, the swabs had high degree of antibacterial activity, but which could be counteracted by the added normal saline （at a dose of 400ml/ swab）. Under the experiments circumstances, average initial bioburden is 5.36CFU/SIP（Sample Item Portion）, a verification dose of4.6kGy is required to give an SAL（sterility assurance level） of 10^-2, while a sterilization dose is found to be 16.8kGy, which is required to give an SAL of 10- 6. The validation for the methods of initial bioburden determination and sterility test were also studied. The recovery rates of Bacillus subtilis, Staphyloccocus aureus Rosenbach, Escherichia coli in three parallels were all no less than 70%. The microorganism growth were all observed of B. subtilis, S. aureus, P. aeruginosa, Clostridium Sporogenes, Candida albicans, Aspergillus niger.