用金黄色葡萄球菌气溶胶评价输液器进气器件细菌截留能力

Evaluation of bacterial retention capacity of air inlet filters of infusion device using challenging aerosol of Staphylococcus aureus

目的设计气溶胶细菌截留试验系统,利用金黄色葡萄球菌气溶胶评价输液器进气器件空气过滤器的细菌截留能力。方法将金黄色葡萄球菌混悬液稀释至10^(8) CFU/mL,利用气溶胶细菌截留试验系统生成气溶胶,对阳性对照支路以及5个生产厂家(A~E)的75个空气过滤器进行测试,采用薄膜过滤法收集液体撞击采样器的采样液,观察是否有菌生长并进行计数。结果测试结束后,阳性对照支路和5个生产厂家A~D的12个批次60个样品的支路收集液均无菌生长,符合要求;生产厂家E 3个批次的15个样品支路收集液菌落数均>100 CFU,不符合要求。生产厂家E的空气过滤器材质为玻璃纤维,孔径为5μm。结论试验设计的气溶胶细菌截留试验系统成功截留输液器进气器件空气过滤器细菌。

Objective To design an aerosol bacterial retention testing to evaluate bacterial retention capacity of air inlet filter of infusion device using challenging aerosol of Staphylococcus aureus.Methods Staphylococcus aureus suspension was diluted to 10^(8) CFU/mL,aerosol was produced by aerosol bacterial retention testing system,positive control branch and 75 air filters from 5 manufacturers(A-E)were tested,membrane filtration method was adopted to collect liquid specimen in the liquid impact sampler,bacteria growth and count was observed.Results After the testing,the collected fluid of positive control branch and 60 specimens from 12 batches of 5 manufacturers(A-D)were without bacteria growth and met the requirements;bacterial colonies of 15 specimens from 3 branches of ma-nufacturer E was>100 CFU,which did not meet the requirements.The air filter of manufacturer E was made of glass fiber with a pore diameter of 5μm.Conclusion The designed aerosol bacterial retention testing system can successfully retain the bacteria in the air inlet filter of infusion devices.