医疗机构制剂生产中纯化水质量控制的实践与探讨.doc

医疗机构制剂生产中纯化水质量控制的实践与探讨
摘要目的:研究纯化水作为医疗机构制剂生产中主要原料及清洗剂的质量监测,确保生产用水质量合格。方法:制定纯化水质量控制的方案,在纯化水各使用点取样,按 2015 年版《中国药典(二部)》最新规定进行化学指标及微生物限度检测,连续 3 个检验周期对其进行质量监测。结果:所生产的纯化水各项化学指标及微生物限度指标均符合规定。结论:为确保制剂工艺用水安全,全面控制纯化水质量尤为重要。
关键词医疗机构制剂纯化水质量控制
中图分类号:R943 文献标识码:C 文章编号:1006-1533(2017)09-0069-04
Practice and discussion of the quality control of purified water in medical institution preparation
WENG Jingyan*, ZHANG Jianzhong**, LYU Qiangzhou, YAO Bangxin, ZHAO Liuya(Department of Pharmacy, Zhongshan Hospital affiliated to Fudan University, Shanghai 200032, China)
ABSTRACT Objective: To investigate the quality control standard for the purified water used as raw material and cleaning agent in medical institution preparations in order to ensure the eligible quality of production water. Methods: The samples of the purified water were collected from different sampling points and examined according to Chinese Pharmacopoeia 2015 edition (Vol. 2), and the chemical items and microbial limit in the water were detected for three consecutive inspection periods (9 weeks). Results: The chemical items and microbial limit indicators in the purified water meet the requirements of current standard. Conclusion: It is particularly important to have a total quality control of purified water in order to ensure the water safety in preparation process.
KEy WORDS medical institution preparation; purifi