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水浴灭菌器布水均匀性确认方法研究
作者姓名:许文东  于鹏  王长城  马秀娟  原江涛
作者单位:1. 山东大学药学院,山东 济南250012;山东齐都药业有限公司,山东 淄博255400;2. 山东齐都药业有限公司,山东 淄博,255400
摘    要:目的 建立一种确认水浴灭菌器布水均匀性的方法,对灭菌器布水均匀性进行评价.方法 通过对水浴灭菌器布水结构的分析,采用在布水口安装螺翼式水表对布水口的水量进行不同时间段的测量,对获得的数据进行显著性差异检验和相对标准偏差(RSD)分析,确认布水是否均匀.结果 通过对布水口单位时间的流量数据统计分析,显著性差异检验结果为15 min流量数据的P值为0.004(表示差异性极显著)、30 min流量数据的P值为0.963(表示差异性不显著)、60 min流量数据的P值为0.024(表示差异性显著);相对标准偏差结果在2.3%至2.9%之间.结论 相对标准偏差对螺翼式水表获得的布水口水量监测数据进行统计评价为确认水浴灭菌器布水均匀性提供了简便和准确的方法.

关 键 词:水浴灭菌器  布水均匀性  显著性差异检验  相对标准偏差

Research on water distribution uniformity confirmation method of water bath sterilizer
Authors:XU Wendong  YU Peng  WANG Changcheng  MA Xiujuan and YUAN Jiangtao
Institution:1.School of Pharmaceutical,Shandong University,Jinan 250014,China;2.Shandong Qidu Pharmaceutical Co., Ltd.,Zibo 255400,China,2.Shandong Qidu Pharmaceutical Co., Ltd.,Zibo 255400,China,2.Shandong Qidu Pharmaceutical Co., Ltd.,Zibo 255400,China,2.Shandong Qidu Pharmaceutical Co., Ltd.,Zibo 255400,China and 2.Shandong Qidu Pharmaceutical Co., Ltd.,Zibo 255400,China
Abstract:Objective To establish a water bath sterilizer confirmed the uniformity of water distribution method,and evaluate the uniformity of water distribution sterilizer.Methods Through the analysis of water bath sterilizer water distribution structure, the spiral wing type water meter installed in the nozzle of cloth on cloth outlet water in different time measurement,the obtained data was analyzed by significant difference test and RSD analysis,and to confirm that the water distribution was whether or not uniform.Results Through statistical analysis of the flow data of unit time,the significant difference test (test significance) results for P value of 15 min traffic data was 0.004(indicating that the difference is very significant), P value of 30 min flow data was 0.963 (indicating that the difference is not significant), P value of60min traffic data was 0.024(indicated significant difference); RSD results from 2.3% to 2.9%.Conclusion RSD of water monitoring data obtained from cloth outlet of spiral wing type water meter were statistically evaluated to confirm the water bath sterilizer water distribution uniformity for providing a simple and accurate method.
Keywords:Water bath sterilizer  Water distribution uniformity  Significant difference test  Relative standard deviation
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