振荡器的使用对静脉用药调配中心百级净化台洁净度的影响
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篇名: 振荡器的使用对静脉用药调配中心百级净化台洁净度的影响
TITLE:
摘要: 目的:了解使用振荡器对静脉用药调配中心百级净化台洁净度的影响。方法:以沉降菌和尘埃粒子数为检测指标,在普通药物配制间、抗菌药物配制间、危害药品配制间中包括生物安全柜、水平层流台不同位置分别布点,监测振荡器在工作和非工作状态下在不同安放位置下百级净化台的洁净度。结果与结论:振荡器在工作和非工作状态下,各监测点的沉降菌和尘埃粒子数均无差异,且均符合2010年版《药品生产质量管理规范》的规定,即振荡器的使用与否及其安放位置对百级净化台的洁净度无影响。从安全角度考虑,建议在使用生物安全柜配制抗菌药物、危害药品时,将振荡器置于净化台内靠左(右)后壁位置。
ABSTRACT: OBJECTIVE: To study the influence of oscillator on the cleanliness of class 100 clean bench in PIVAS. METHODS: Using sedimentated bacteria and the number of dust particle as index, in common drug configuration room, antibiotics configuration room and risk drugs configuration room including biological safety cabinet and horizontal laminar flow, the cleanliness of class 100 clean bench were monitored when oscillator was set at clean bench and different positions in work and non-working state. RESULTS & CONCLUSIONS: In working and non-working state of oscillator, there was no difference in sedimentated bacteria and the number of dust particle which was in line with the requirements of 2010 edition of GMP, i.e. the application and location of oscillator didn’t influence the cleanliness of class 100 clean bench. From a view of safety, it is suggested to place the oscillator in the left (or right) posterior wall of clean table when biological safety cabinets is used to dispense antibiotic and risk drugs.
期刊: 2016年第27卷第1期
作者: 谢继青,石继明,赵文静,于燕莉
AUTHORS: XIE Jiqing,SHI Jiming,ZHAO Wenjing,YU Yanli
关键字: 振荡器;净化台;洁净度;静脉用药调配中心
KEYWORDS: Oscillator; Clean bench; Cleanliness; Pharmacy intravenous admixture services
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