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目的:了解陕西省范围内医疗器械生产厂家洁净厂房洁净质量情况,为医疗器械生产厂家提高医疗器械生产环境质量提供依据。方法:根据GB/T 16292-2010《医药工业洁净室(区)悬浮粒子的测试方法》、GB/T 16293-2010《医药工业洁净室(区)浮游菌的测试方法》、GB/T 16294-2010《医药工业洁净室(区)沉降菌的测试方法》、YY0033-2000《无菌医疗器具生产管理规范》的要求,对本地区的17家医疗器械厂家洁净区的温度、湿度、风速、换气次数、静压差、尘埃粒子、浮游菌、沉降菌进行检测和评价。结果:4年共检测医疗器械厂家17家,洁净厂房236间。温度合格率100%,湿度合格率100%,风速合格率100%,换气次数合格率94%,静压差合格率97%,尘埃粒子合格率90%,浮游菌合格率98%,沉降菌合格率98%。结论:应加强环境控制及人员控制,严格按照YY 0033-2000《无菌医疗器具生产管理规范》的要求定期对洁净厂房进行监测,制定详尽的洁净厂房使用规程,并让操作人员严格遵守,切实把好无菌医疗器械生产关。
Objective: To understand the cleanliness of the clean room of medical device manufacturers in Shaanxi province and to provide basis for the medical device manufacturers to improve the quality of medical device manufacturing environment. Methods: According to GB / T 16292-2010 “Test Method for Suspended Particles in Pharmaceutical Industry Cleanroom (Region)”, GB / T 16293-2010 “Test Methods for Planktonic Bacteria in Pharmaceutical Industry Cleanrooms”, GB / T 16294- 2010 “test method for settling bacteria in the clean room (area) of the pharmaceutical industry”, YY0033-2000 “Management Specification for Sterile Medical Devices”, the temperature, humidity, wind speed and ventilation of the clean area of 17 medical device manufacturers in this area Frequency, static pressure, dust particles, planktonic bacteria, sedimentation bacteria were detected and evaluated. Results: In the past 4 years, 17 medical device manufacturers and 236 clean factories were detected. Temperature pass rate of 100%, humidity pass rate of 100%, the wind speed pass rate of 100%, the number of ventilation pass rate of 94%, static pressure pass rate of 97%, 90% pass rate of dust particles, Pass rate of 98%. Conclusion: Environmental control and personnel control should be strengthened, and clean factory premises should be regularly monitored according to the requirements of YY 0033-2000, “Sterilized Medical Device Production Management Practices,” and exhaustive procedures for the use of clean factory premises should be established. Operators should strictly abide by and practice Good sterile medical equipment production off.