药包材密度测定能力验证结果与分析

Results and Analysis for the Proficiency Testing of the Density Determination Ability of Pharmaceutical Packaging Materials

目的提高药品包装材料(简称药包材)检测的质控能力。方法根据中国合格评定国家认可委员会(CNAS)相关文件要求,委托药包材生产企业制备样品。实验室按2020年版《中国药典(四部)》通则4012药包材密度测定法对样品进行能力验证试验,将均匀性和运输稳定性试验合格的样品随机发放给参加能力验证的41家机构,回收评定结果,采用z比分数评价实验室的测定能力。结果参加该次能力验证的41家机构中,40家机构的能力验证结果评定为满意,满意率为97.56%,满意结果范围为0.945~0.951 g/cm3。结论绝大部分实验室具备使用药包材密度测定法测定塑料密度的能力。

Objective To improve the quality control ability of pharmaceutical packaging materials testing.Methods According to the requirements of the relevant documents of the China National Accreditation Service for Conformity Assessment(CNAS),the samples were prepared by a pharmaceutical packaging material manufacturer.The laboratory conducted proficiency testing of samples in accordance with the density determination method for pharmaceutical packaging materials in the general rule 4012 of the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ).After passing the homogeneity and stability test,the samples were randomly distributed to 41 institutions participating in the proficiency testing,and the evaluation results were collected.The laboratory's testing ability was evaluated by the z score.Results Among the 41 institutions participating in the proficiency testing,40 institutions were evaluated as satisfactory,with a satisfaction rate of 97.56%and a satisfaction range of 0.945-0.951 g/cm3.Conclusion Most laboratories have the ability to use the density measurement method of pharmaceutical packaging materials to determine the density of plastics.