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| 医药洁净室及相关受控环境标准研究 |
| Research of Standards for Cleanrooms and Associated Controlled Enviroments |
| 投稿时间：2020-03-13 修订日期：2020-09-07 |
| DOI： |
| 中文关键词: 空气洁净度 悬浮粒子 浮游菌 |
| 英文关键词: cleanliness airborne particle airborne microbe settling microbe |
| 基金项目: |
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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，需标准制定部门协调统一，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 Standards for Cleanrooms. Associated Controlled Enviroments and discuss the questions and problem in Domestic Standards. Methods: To compose, compare, analyse and discuss the detection methods and Criterion of different Standard. Results and Conclusion: The domestic Standards for Cleanrooms and Associated Controlled Enviroments have various questions and problems, include confusion and delay. Related department of Standard-setting ought to coordinate and revise promptly. And it is necessary to establish a standard system .We also should strengthen the testing and monitoring of the environment to ensure the safety of drug production and medical environment. |
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