基于激光诱导荧光技术原理的微生物实时监测技术在USP<1223>标准下的替代验证及其在PIVAS洁净室的应用研究

Verification of Real-time Microbial Monitoring Technology Based on the Principle of Laser-induced Fluorescence Under USP<1223> Standard and Application in Hospital PIVAS Clean Room

关键词:  静脉用药集中调配中心  生物气溶胶  激光诱导荧光  浮游菌  悬浮粒子  实时监测系统

Key words:  pharmacy intravenous admixture services(PIVAS)  bio-aerosol  laser-induced fluorescence  planktonic bacteria  suspended particles  real-time monitoring system

摘要:

目的 为实现给静脉用药集中调配中心（pharmacy intravenous admixture services，PIVAS）对浮游菌及尘埃粒子的实时监测及预警提供技术支持，依据美国药典（USP）微生物替代方法验证的要求，对微生物实时监测技术进行微生物替代方法可行性验证，并研究该技术与传统浮游菌及尘埃粒子测试方法的效果差异。方法 通过对激光诱导荧光技术的生物气溶胶实时监测系统（biological aerosol real-time monitoring system，BAMS）与浮游菌采样器在线性相关性、准确度、精密度、专属性、定量限、重现性和耐用性等关键参数的数据比对，验证替代方案的可行性。在PIVAS洁净室分别对BAMS、浮游菌采样器及尘埃粒子检测仪的实际应用效果进行比较评估。结果 BAMS相较于传统的浮游菌采样器具有显著的灵敏度优势，回收率、精密度、专属性、线性、重现性及耐用性等验证指标均符合USP<1223>项下的相关要求，BAMS在PIVAS洁净区的尘埃粒子检测效率与传统方法无明显差异。结论 BAMS与传统洁净区环境监测方法无差异，且比传统的浮游菌采样器具备更高的检测灵敏度及时效性，可应用于医院PIVAS洁净室环境微生物污染状况的实时监测。

Abstract:

OBJECTIVE In order to provide technical support for the real-time monitoring and early warning of pharmacy intravenous admixture services(PIVAS) to the planktonic bacteria and dust particles, the feasibility of substituted method of real-time monitoring technology was verified, and the comparison of the application of this technology versus traditional planktonic bacteria and dust particle testing methods was carried out, in accordance with the requirements of the U.S. Pharmacopeia(USP) for the feasibility verification of substitution methods. METHODS First of all, the feasibility of the substituted method was verified through the comparison of key parameters data such as linear correlation, accuracy, precision, specificity, quantitative limit, reproducibility and durability between a biological aerosol real-time monitoring system(BAMS) and the traditional air plankton sampler. Secondly, the actual application effects of the BAMS, plankton-sampler and dust particle counter were compared and evaluated in the PIVAS clean room. RESULTS The BAMS had a significant sensitivity advantage over the traditional plankton-sampling apparatus, and its verification indexes, such as recovery, precision, specificity, linearity, reproducibility and durability, all met the relevant requirements under USP<1223>. There was no significant difference in the dust particle counting efficiency of BAMS in PIVAS clean area compared with the traditional method. CONCLUSION The BAMS is not different from the traditional environmental monitoring method in clean area, and has higher detection sensitivity and timeliness than the traditional planktonic bacteria sampler. The BAMS can be applied to the real-time monitoring of environmental microbial pollution in hospital PIVAS clean room.