Christensen E A, Kristensen H, Hoborn J, Miller A
Control Department, Statens Seruminstitut, Copenhagen, Denmark.
APMIS. 1991 Jul;99(7):620-6. doi: 10.1111/j.1699-0463.1991.tb01236.x.
Three different methods were used for detecting and isolating microorganisms with high radiation resistance from the microbial contamination on infusion sets prior to sterilization. By all three methods, microorganisms with a radiation resistance high enough to be a critical factor in a sterilization process (D-6 value greater than or equal to 30 kGy) were found with a frequency of approximately two colony forming units (cfu) per 100 product items, even though the product items in two of the series of analyses were irradiated with doses of 3-6 kGy. The frequency of occurrence of isolates with D-6 values greater than or equal to 30 kGy was 0.45 per 1000 cfu of the total aerobic count. Eight different isolates of microorganisms had D-6 values greater than or equal to 40 kGy when irradiated in dried laboratory preparation. All but one of these were classified according to morphologic criteria as Deinococcus, and all but one had nonlinear dose-response relationships in semilogarithmic presentation.
采用三种不同方法,从灭菌前输液器上的微生物污染中检测和分离具有高抗辐射性的微生物。通过这三种方法,均发现了抗辐射性足以成为灭菌过程关键因素的微生物(D-6值大于或等于30 kGy),其出现频率约为每100个产品项目中有两个菌落形成单位(cfu),尽管在两个系列分析中的产品项目已接受3-6 kGy的辐照剂量。D-6值大于或等于30 kGy的分离株在总需氧菌数中每1000 cfu的出现频率为0.45。八种不同的微生物分离株在干燥实验室制剂中辐照时D-6值大于或等于40 kGy。除其中一株外,其余均根据形态学标准归类为嗜放射菌属,并且除其中一株外,所有菌株在半对数表示中均具有非线性剂量反应关系。