Ceccanti Stefano, Giampieri Simona, Burgalassi Susi
AbiogenPharma, Via Meucci 36, I-Ospedaletto, Pisa, Italy.
PDA J Pharm Sci Technol. 2011 Jul-Aug;65(4):372-9. doi: 10.5731/pdajpst.2011.00723.
The aim of the present investigation was to evaluate the microbial efficacy against highly resistant bacterial spores on different substrates using the lowest effective concentration of a market liquid sporicide based on peracetic acid. The validation was carried out following modified European regulatory agencies procedures or test methods and USP guidelines, employing carriers of materials usually treated with the sporicidal solution and present in grade A cleanrooms and spores of four different microorganisms: Bacillus subtilis and Clostridium sporogenes, both from the ATCC collection, and Bacillus cereus and Bacillus sphaericus as environmental isolates. A statistical evaluation of data was made to estimate the variance for different study conditions. The experiments highlighted that 70% suitable dilution of the ready-to-use peracetic acid solution was effective in both clean and dirty conditions, showing at least 2 log spore reduction after treatment. To obtain effective sporicidal action on the surfaces in cleanrooms it is sufficient to use a sporicidal solution with a ready-to-use concentration of 70% while ensuring a contact time of 10 min. In any case, the reduction of sporicide concentration ensures a high degree of disinfection and provides a consumption savings.
Wide-spectrum disinfectants are used in the pharmaceutical industry for the decontamination of work surfaces and equipment, but these products have some degree of toxicity for operators. This work arises from the needs of pharmaceutical companies to find the lowest effective concentration of sanitizers in order to reduce toxicity to personnel. The sanitizer used in the study was a market liquid sporicide based on peracetic acid. When we started our work no similar studies were reported in the literature, so we took European regulatory agencies and USP guidelines as a starting point, employing carriers of hard, non-porous materials usually treated with the sporicidal solution and present in sterile rooms and spores of four different microorganisms. The experiments highlighted that it is sufficient to use a 70% sporicidal solution concentration with a contact time of 10 min to reduce the number of spores to acceptable values for medicinal production. The reduction of sporicide concentration both ensures a high degree of disinfection and provides a safer working environment and consumption savings.
本研究的目的是使用市售基于过氧乙酸的液体杀孢子剂的最低有效浓度，评估其对不同底物上高度耐药细菌孢子的微生物杀灭效果。验证按照欧洲监管机构修改后的程序或测试方法以及美国药典指南进行，采用通常用杀孢子溶液处理且存在于A级洁净室的材料载体，以及四种不同微生物的孢子：均来自美国典型培养物保藏中心（ATCC）的枯草芽孢杆菌和生孢梭菌，以及作为环境分离株的蜡样芽孢杆菌和球形芽孢杆菌。对数据进行了统计评估，以估计不同研究条件下的方差。实验表明，即用型过氧乙酸溶液70%的合适稀释液在清洁和脏污条件下均有效，处理后孢子减少至少2个对数级。要在洁净室表面获得有效的杀孢子作用，使用即用浓度为70%的杀孢子溶液并确保接触时间为10分钟就足够了。无论如何，降低杀孢子剂浓度可确保高度消毒并节省用量。
广谱消毒剂在制药行业用于工作表面和设备的去污，但这些产品对操作人员有一定程度的毒性。这项工作源于制药公司寻找消毒剂最低有效浓度以降低对人员毒性的需求。研究中使用的消毒剂是市售基于过氧乙酸的液体杀孢子剂。当我们开始这项工作时，文献中没有类似研究报道，所以我们以欧洲监管机构和美国药典指南为起点，采用通常用杀孢子溶液处理且存在于无菌室的硬质无孔材料载体以及四种不同微生物的孢子。实验表明，使用浓度为70%的杀孢子溶液并接触10分钟足以将孢子数量减少到药物生产可接受的值。降低杀孢子剂浓度既能确保高度消毒，又能提供更安全的工作环境并节省用量。
