| 李笑蕾,倪明.医药洁净室及相关受控环境标准研究[J].中国药事,2020,34(10):1165-1170 |
| 医药洁净室及相关受控环境标准研究 |
| On Standards for Cleanrooms and Associated Controlled Environments |
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| DOI：10.16153/j.1002-7777.2020.10.007 |
| 中文关键词: 空气洁净度 悬浮粒子 浮游菌 沉降菌 |
| 英文关键词: cleanliness airborne particle airborne microbe settling microbe |
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| 中文摘要: |
| 目的：对国内医药洁净室及相关环境的标准进行比对，探讨医药洁净环境相关标准存在的问题。 方法：对医药洁净环境的相关标准从检测方法、判定标准等方面分别进行组合、比对、分析和讨论。结果与结论：国内医药洁净室及相关环境的标准存在相对混乱、滞后等现象，需标准制定机构协调统一， 建立标准体系；同时，应加强环境的检测与监测力度，共同保障药品生产安全与医疗环境安全。 |
| 英文摘要: |
| Objective: To compare the domestic pharmaceutical cleanrooms and related environmental standards, and discuss the problems of pharmaceutical clean environment related standards. Methods: To compose, compare, analyse and discuss the relevant standards of medical clean environment from aspects of detection methods and determination criterion. Results and Conclusion: The domestic Standards for Cleanrooms and Associated Controlled Environments had various questions and problems, including confusion and delay. Related department of Standard-setting ought to coordinate and revise promptly. And it is necessary to establish a standard system. At the same time, environmental testing and monitoring should be strengthened to jointly ensure the safety of drug production and medical environment. |
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