Jeng D K, Woodworth A G
Baxter Healthcare Corporation, Baxter Technology Park, Round Lake, Illinois 60073.
Artif Organs. 1990 Oct;14(5):361-8. doi: 10.1111/j.1525-1594.1990.tb02981.x.
Artificial organ oxygenators, with large surface areas and complicated structures, were sterilized using chlorine dioxide gas in an industrial scale sterilizer. Bacillus subtilis var. niger ATCC 9372 biological indicators (BI) (10(6) spores/BI) planted in the artificial organs were reproducibly sterilized in a designed cycle schedule with a 30-min dwell time with a chlorine dioxide gas concentration of approximately 30 mg/L in 80 to 85% relative humidity at 30 degrees C. The D value (time required for 90% spore inactivation under specific conditions) was estimated to be 4.4 min. Chlorine dioxide was not detected after post-sterilization aeration. The intravenous median lethal dose (LD50) of chlorine dioxide derivatives, chlorite and chlorate, in rats was found to be 112.8 and 2,228.6 mg/kg, respectively. In an immediate hypersensitivity test, chlorine dioxide gas-treated ovalbumin and bovine serum albumin, unlike ethylene oxide gas-treated proteins, did not cause sterilant-specific IgE-mediated hypersensitivity reactions in rats. Results of an Ames mutagenicity test on chlorine dioxide and on the extracts of the chlorine dioxide gas-exposed oxygenators were negative.
人工器官氧合器表面积大、结构复杂，在工业规模的灭菌器中使用二氧化氯气体进行灭菌。接种在人工器官中的枯草芽孢杆菌黑色变种ATCC 9372生物指示剂（BI）（10⁶个孢子/BI），在30℃、相对湿度80%至85%、二氧化氯气体浓度约为30mg/L的条件下，按照设计的循环程序，在30分钟的停留时间内可重复实现灭菌。D值（特定条件下使90%的孢子失活所需的时间）估计为4.4分钟。灭菌后通气未检测到二氧化氯。大鼠体内二氧化氯衍生物亚氯酸盐和氯酸盐的静脉注射半数致死剂量（LD50）分别为112.8mg/kg和2228.6mg/kg。在即刻超敏反应试验中，与环氧乙烷气体处理的蛋白质不同，二氧化氯气体处理的卵清蛋白和牛血清白蛋白未在大鼠中引起灭菌剂特异性IgE介导的超敏反应。对二氧化氯以及暴露于二氧化氯气体的氧合器提取物进行的艾姆斯致突变试验结果均为阴性。
