过氧化氢干雾灭菌器用于GMP车间的空间消毒效果研究

Research on space disinfection efficacy of using hydrogen peroxide dry mist sterilizer in GMP workshop

目的观察过氧化氢空间喷雾消毒技术用于GMP车间的空间消毒效果,为评估该方法在车间日常清洁消毒中的实际运用提供依据。方法选择GMP车间中空间体积和空间布局均有较大差异的3个洁净区域D、E和F,同时采用化学指示卡和生物指示剂判定法,分别观察过氧化氢干雾灭菌器采用不同消毒剂剂量在各个区域的空间消毒效果。结果D区为直线型人物流通道,仅一侧分布功能性房间,最佳消毒剂剂量为6 ml/m^(3);E区为含少量拐弯的直线型人物流通道,两侧均分布功能性房间,最佳消毒剂剂量为8 ml/m^(3);F区为L型人物流通道,两侧均分布功能性房间,最佳消毒剂剂量为10 ml/m^(3)。结论过氧化氢干雾灭菌器的空间消毒效果能够达到中国药典2020年版四部规定的灭菌标准。其实际消毒效果与车间空间布局复杂程度呈负相关,与消毒剂的剂量呈正相关,即布局复杂的车间,通过适当增加消毒剂用量可提高空间消毒效果。

Objective To evaluate the space disinfection efficacy of using hydrogen peroxide dry mist sterilizer in GMP workshop,to provide a basis for appraising the practical application of this method in daily cleaning and disinfection of workshop.Methods Three clean zones named D,E and F with different space volumes and special arrangements in GMP workshop were chosen and space disinfection efficacy of hydrogen peroxide dry mist sterilizer with different doses of disinfectant in different zones was assessed by the chemical indicators and biological indicators at the same time,respectively.Results Zone D was a linear flow channel with functional rooms on one side,and the best disinfectant dose of this zone is 6 ml/m^(3).Zone E was a linear flow channel with a few turns and functional rooms on both sides,and the best disinfectant dose was 8 ml/m^(3).Zone F was L-shaped flow channel with functional rooms distributed on both sides,and the best disinfectant dose was 10 ml/m^(3).Conclusion The space disinfection effect of hydrogen peroxide dry mist sterilizer can reach the sterilization standard stipulated by Chinese pharmacopoeia 2020 edition volumeⅣ.The actual disinfection effect is negatively correlated with the complexity of workshop space layout and positively correlated with the dose of disinfectant.In the workshop with complex layout,the space disinfection effect can be improved by appropriately increasing the dosage of disinfectant.