Sadeghi Simin, Abdollahi Soosan, Tarighi Parastoo, Samadi Nasrin
Department of Drug and Food Control, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Department of Pharmaceutics, Faculty of Pharmacy, Lorestan University of Medical Sciences, Khorramabad, Iran.
Iran J Microbiol. 2020 Apr;12(2):113-120.
There are different sporicidal standard tests with various specifications to deal with products that are claimed for sporicidal activity. The aim of this study was to compare the 7% HO sporicidal efficacy against spores using different standard test methods.
The 7% HO sporicidal efficacy against spores was determined according to the AOAC MB-15-04 standard of carrier test and two standard suspension tests (BS EN 13704, AFNOR NF 72-230) in both clean and dirty conditions and by using different interfering substances including bovine serum albumin, yeast extract and skimmed milk.
The results of suspension tests with 3 × 10 and 2 × 10 CFU/ml of spore concentration demonstrated that the higher spore counts lead to lower efficacy of 7% HO. Also, the sporicidal activity of 7% HO was reduced in the presence of interfering substances. Bovine serum albumin, yeast, and skimmed milk showed similar interfering effects in suspension test with 3 × 10 CFU/ml. While, in suspension tests with higher initial spore count (2 × 10 CFU/ml) severity of interfering effects were intensified and distinct. Our results indicated that the carrier sporicidal test in comparison with suspension tests required more contact time to kill spores.
The results of this study showed that it is reasonable to use interfering substances and inoculated carriers in accordance with actual conditions of product usage in a sporicidal test. Interfering substances may reduce the contact surface between HO and test spores; therefore, the sporicidal efficacy of HO was diminished. So applying suspension test in clean condition to verify the claim of sporicidal activity is strongly discouraged.
针对宣称具有杀孢子活性的产品,有不同规格的杀孢子标准测试。本研究的目的是使用不同的标准测试方法比较7%过氧化氢对孢子的杀孢子效果。
根据AOAC MB - 15 - 04载体测试标准以及两种标准悬液测试方法(BS EN 13704、AFNOR NF 72 - 230),在清洁和污染条件下,使用包括牛血清白蛋白、酵母提取物和脱脂牛奶在内的不同干扰物质,测定7%过氧化氢对孢子的杀孢子效果。
孢子浓度为3×10和2×10 CFU/ml的悬液测试结果表明,孢子数量越多,7%过氧化氢的效果越低。此外,在存在干扰物质的情况下,7%过氧化氢的杀孢子活性降低。在孢子浓度为3×10 CFU/ml的悬液测试中,牛血清白蛋白、酵母和脱脂牛奶显示出相似的干扰效果。然而,在初始孢子数较高(2×10 CFU/ml)的悬液测试中,干扰作用的严重程度加剧且明显。我们的结果表明,与悬液测试相比,载体杀孢子测试需要更长的接触时间来杀灭孢子。
本研究结果表明,在杀孢子测试中根据产品实际使用条件使用干扰物质和接种载体是合理的。干扰物质可能会减少过氧化氢与测试孢子之间的接触表面;因此,过氧化氢的杀孢子效果降低。所以强烈不建议在清洁条件下应用悬液测试来验证杀孢子活性的宣称。