药物临床试验药房冰箱超温原因分析及预防措施
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篇名: | 药物临床试验药房冰箱超温原因分析及预防措施 |
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摘要: | 目的:分析药物临床试验药房冰箱超温原因,探讨处理方法和预防措施。方法:统计我院药物临床试验药房2011年1月-2016年4月期间冰箱超温情况,进行超温原因分析。结果:2011年1月-2016年4月,共发生32次冰箱超温。在超温原因中,冰箱开门时间过长占31.25%,停电占18.75%,温度计探头放置位置不合理占18.75%,外界温度过高占12.50%,冰箱故障及储存药品超过冰箱容量3/4均占9.37%。其中,有31次超温发生在2011年1月-2015年1月;2015年2月药物临床试验药房启用冷链监控后,至2016年4月只发生了1次超温,超温原因是冰箱损坏。结论:医用冰箱在使用过程中由于各种原因可能发生超温情况,而通过安装温控监测等措施可有效降低超温的发生率。在药物临床试验药房使用冷链监控很有必要。 |
ABSTRACT: | OBJECTIVE: To analyze the reasons for refrigerator over-temperature of GCP pharmacy, and to discuss the treatment methods and preventive measures. METHODS: A total of 32 times of over-temperature situation occurred in GCP pharmacy of our hospital during Jan. 2011 to Apr. 2016, and their reasons were analyzed statistically. RESULTS: Among the reasons for over-temperature, opening the refrigerator door for a long time accounted for 31.25%; blackout accounted for 18.75%; unreasonable thermometer probe placement accounted for 18.75%; external high temperature accounted for 12.50%; refrigerator fault and drug storage in refrigerator more than 3/4 capacity accounted for 9.37%. 31 times of over-temperature situation occurred during Jan. 2011 to Jan. 2015. Only once occurred in Apr. 2016 since cold chain monitoring was used in Feb. 2015, and refrigerator fault was the reason for it. CONCLUSIONS: Over-temperature for medical refrigerator may be caused by various reasons, and cold chain monitoring can effectively reduce the incidence of over-temperature, and the cold chain monitoring is necessary for clinic. |
期刊: | 2016年第27卷第28期 |
作者: | 杨樱,容颖慈,喻丽元,叶毅芳 |
AUTHORS: | YANG Ying,RONG Yingci,YU Liyuan,YE Yifang |
关键字: | 临床试验药品;冷链监控;超温;原因分析 |
KEYWORDS: | Clinical trial drugs; Cold chain monitoring; Over-temperature; Reason analysis |
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