Miner N A, Taylor M A, Bernal S E, Harris V L, Sichinga M J
MicroChem Laboratory, Inc, Fort Worth, TX 76118, USA.
J AOAC Int. 2001 Jul-Aug;84(4):1159-63.
In the United States, the AOAC Sporicidal Activity of Disinfectants Method 966.04 is the standard for identifying a liquid chemical germicide as a sterilant. Furthermore, the highest level of a disinfectant must also be a sterilant as defined by Method 966.04, when used in its sterilant mode for a longer exposure time. The AOAC Sporicidal Test is also used as a part of the standard test methods to define a sterilant for Australia and the European Union. Many laboratories have identified variables of this test that can affect the sterilization exposure time for sterilants, or even the ability to classify a chemical as a sterilant. Method 966.04 requires spore-labeled porcelain penicylinders (cylinders) and silk suture loops, collectively referred to as carriers, to be dried for 24 h, but allows these carriers to be used for at least 7 days, in effect allowing a drying time of 24 h to at least 7 days. We tested the resistance of cylinders that had been labeled with Bacillus subtilis spores cultured for 72, 96, and 120 h, and dried for 24, 48, and 72 h against a 60 min exposure to 2.0% alkaline glutaraldehyde, and 2, 5, 10, 15, and 20 min exposures to 2.5N HCl. All the culture incubation and drying times met the standard of resistance to 2.5N HCI for at least 2.0 min at 20 degrees C, and all carriers contained at least 10(5) colony-forming units (CFU) of B. subtilis per carrier. However, for 3 repeated tests, regardless of incubation time, an average of 96% of the carriers were sterilized by the 2.0% glutaraldehyde after drying for 24 h, and an average of 61 % were sterilized after drying for 48 or 72 h. We propose that the variable of drying time be eliminated from Method 966.04.
在美国，《美国官方分析化学师协会消毒剂杀孢子活性方法966.04》是将液体化学杀菌剂鉴定为灭菌剂的标准。此外，当消毒剂以其灭菌模式使用更长的暴露时间时，其最高级别也必须是《方法966.04》所定义的灭菌剂。《美国官方分析化学师协会杀孢子试验》也用作澳大利亚和欧盟定义灭菌剂的标准测试方法的一部分。许多实验室已经确定了该试验的变量，这些变量会影响灭菌剂的灭菌暴露时间，甚至影响将一种化学品归类为灭菌剂的能力。《方法966.04》要求先用芽孢标记瓷质青霉素瓶（瓶子）和丝线缝合环，统称为载体，干燥24小时，但允许这些载体至少使用7天，实际上允许干燥时间从24小时到至少7天不等。我们测试了用培养72、96和120小时的枯草芽孢杆菌芽孢标记，并分别干燥24、48和72小时的瓶子，在暴露于2.0%碱性戊二醛60分钟，以及暴露于2.5N盐酸2、5、10、15和20分钟后的抗性。所有培养孵育和干燥时间均符合在20℃下对2.5N盐酸至少耐受2.0分钟的标准，并且所有载体每个载体至少含有10⁵个枯草芽孢杆菌菌落形成单位（CFU）。然而，在3次重复试验中，无论孵育时间如何，干燥24小时后，平均96%的载体被2.0%戊二醛灭菌，干燥48或72小时后，平均61%的载体被灭菌。我们建议从《方法966.04》中消除干燥时间这一变量。
