药品冷链验证和冷链储运中的盲点及对策探索

Blind Spots in the Drug Cold Chain Verification and Cold Chain Storage and Transportation and the Countermeasures

目的探讨药品冷链验证和冷链储运过程中盲点的可行性测试方法和对策,方法结合企业多年的冷链验证,冷链储运经验对两项过程中的盲点进行分析和归纳。采用Exoel软件绘制散点图,全面呈现平均温度、温度波动、温度离散等信息;建立库房温度均匀性的判断方法,并结合散点图对“冷点”和“热点”进行准确定位。结果与结论发现温度分布数据呈现不全面、温度分布缺少均匀性评价、缺少保温箱箱体性能判断、缺少蓄冷剂性能判断﹑忽略收货时间测试等盲点,在日常运营中应不断总结不足和盲点,并利用科学的方法进行分析和探索,以减少冷链风险,有效提升冷链管理水平。

Objective To investigate the feasibility test method and coumtermeasures of the blind spot in the drug cold chain validationand cold chain storage and transportation.Methods Based on years of cold chain verificatiom and cold chain storage and tramsportaionexperience,the blind spaots in the two processes were analyzed and summarized.Excel sofware was used to draw the seatter plots,whichshowed the average temperature,temperature fluctuation,temperature dispersion and other information comprehensively.A method forjudging the temperature umiformity of the warehouse wasestabhlished,the“cold spots”and“hot spots”were accurately located in combi-nation with scatfer plots.Results and Conclusion lt was fumd that there were some Hlind spots such as incomplete presentation oftemperature ditribution data lack of uniformity evaluation of temperature distribution,lack of performance judgment of heat preservationbox,lack of performance judgment of cold storage agent,and neglect of receiving time test.lt is an effctive way to reduce the risk ofcold chain and improve the management level of cold chain management by sunmarizing the shortcomings and blind spots in daly operation and using scientific methods to analyze and explore.