智能静脉用药调配系统洁净度验证

Validation of Cleanness of Intelligent Intravenous Drug Dispensing System

目的促进静脉用药调配质量管理模式创新。方法对安装在普通环境下的全自动高速智能配液系统APAS-600配液区静态和动态条件下洁净环境的风速、悬浮粒子、空气浮游菌、空气沉降菌进行测试。结果APAS-600在普通环境下运行,配液区洁净度在静态和动态条件下风速分别为(0.43±0.03)m/s及(0.44±0.4)m/s,≥0.5μm的悬浮粒子分别为669个/m^(3)和264个/m^(3),≥5.0μm的悬浮粒子为0个/m^(3),空气浮游菌、空气沉降菌分别为0 cfu/(皿·0.5 h)及0 cfu/(皿·4 h),符合《药品生产质量管理规范(2010年修订)》A级洁净度要求。结论高速智能配液系统APAS-600无菌调配技术可解决静脉用药调配中心(PIVAS)仅能在万级净化环境下调配静脉用药的局限性问题,无需生物安全柜或水平层流台等设备,即可满足PIVAS日常静脉药物调配工作,促进了静脉药物调配智能化发展。

Objective To promote the innovation of quality management mode of intravenous drug dispensing.Methods The wind speed,airborne particles,settling microbe and airborne microbe of full-automatic high-speed intelligent liquid dispensing system APAS-600 were tested under static and dynamic working conditions in general environmental conditions.Results APAS-600 worked in general environmental conditions.Under static and dynamic conditions,the cleanliness of the intravenous dispensing area was(0.43±0.03)m/s and(0.44±0.4)m/s respectively,the number of airborne particles≥0.5μm were 669 per m^(3) and 264 per m^(3) respectively,the number of airborne particles≥5μm were 0 per m^(3),and the airborne particles and airborne bacteria were 0 cfu/(vessel·0.5 h)and 0 cfu/(vessel·4 h)respectively,which met the grade A cleanliness requirements of the Pharmaceutical Production Quality Management Specification(2010 Revision).Conclusion The aseptic dispensing technology of high-speed intelligent dispensing system APAs-600 can solve the limitation that pharmacy intravenous admixture service(PIVAS)can dispense intravenous drugs only in a ten-thousand level purification environment.It does not need biological safety cabinet or horizontal layer flow platform and other equipment to meet the daily intravenous drug dispensing work of PIVAS,which promote the intelligent development of intravenous drug dispensing.