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药品运输包装的性能测试浅析

牛寒冬, 连潇嫣, 高蕾, 王亚敏

牛寒冬, 连潇嫣, 高蕾, 王亚敏. 药品运输包装的性能测试浅析[J]. 中国药科大学学报, 2017, 48(6): 751-758. DOI: 10.11665/j.issn.1000-5048.20170619
引用本文: 牛寒冬, 连潇嫣, 高蕾, 王亚敏. 药品运输包装的性能测试浅析[J]. 中国药科大学学报, 2017, 48(6): 751-758. DOI: 10.11665/j.issn.1000-5048.20170619
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NIU Handong, LIAN Xiaoyan, GAO Lei, WANG Yamin. A review on the performance testing for transport packages of pharmaceutical products[J]. Journal of China Pharmaceutical University, 2017, 48(6): 751-758. DOI: 10.11665/j.issn.1000-5048.20170619
Citation: NIU Handong, LIAN Xiaoyan, GAO Lei, WANG Yamin. A review on the performance testing for transport packages of pharmaceutical products[J]. Journal of China Pharmaceutical University, 2017, 48(6): 751-758. DOI: 10.11665/j.issn.1000-5048.20170619
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药品运输包装的性能测试浅析

  • 国家食品药品监督管理总局药品审评中心

A review on the performance testing for transport packages of pharmaceutical products

摘要

    摘要
  • 摘要: 运输包装是以运输储存为主要目的的产品包装，其性能优劣将直接影响货物流通期间的产品质量。药品开发过程中，国内企业往往较为重视内包装的选择与研究，而容易忽视药品流通过程中潜在的运输风险，忽略对运输包装实际性能的有效检测及评价。本文论述了药品运输包装性能测试的必要性，分析对比了国内外药品申报注册的相关现状，并通过介绍药品运输包装的性能测试中的可参考标准，尤其是美国材料与试验协会《运输容器系统性能检测标准规范》(ASTM D4169)，以期为药品运输包装的性能测试及评价提供相应思路及参考。
    Abstract: The transport packages are primarily developed for transportation and storage, whose capabilities directly affect the product qualities during the circulation. During pharmaceutical development, the domestic pharmacy enterprises tend to put emphasis on the inner packing, but neglect the potential hazard elements in the distribution cycles and performance tests for transport packages of pharmaceutical products, which ultimately result in the disregard of hidden quality peril. This paper analyzes the necessity and significance ofthe performance tests for pharmaceuticals, follow by its domestic and overseas status. And then several testing standards for transport packages, especially ASTM D4169(Standard Practice for Performance Testing of Shipping Containers and Systems), are introduced in order to provide some suggestions of the performance testing for transport packages of pharmaceutical products.
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    • 参考文献(15)
  • [1] China Food and Drug Administration.药品包装、标签和说明书管理规定(暂行)(局令第23号)[EB/OL].(2000-10-15)[2017-09-23] .http://www.sda.gov.cn/WS01/CL0053/15767.html.
    [2] General Administration of Quality Supervision, Inspection and Quarantine of the People′s Republic of China,Standardization Administration of the People′s Republic of China.GB/T 9174-2008 General specification for transport packages of general cargo [一般货物运输包装通用技术条件][S].Beijing:Standards Press of China,2008.
    [3] Guo YF,Fu YG,Xu WC,et al.Performance test and evaluation technology for transport packaging[J].Packaging Engineering(包装工程),2006(4):26-28.
    [4] U.S.Food and Drug Administration.Guidance for Industry-Container closure systems for packaging human drugs and biologics [EB/OL].(1999-07-07)[2015-11-13] .https://www.fda.gov/downloads/Drugs/GuidanceComplianceregulatory-Information/Guindances/ucm070553.pdf.
    [5] Huang YL,Yan JL.Interpretation of testing standards of the transport packages[J].包装世界,2012(4):21-23.
    [6] International Safe Transit Association.Guidelines for Selecting and Using ISTA® Test Procedures and Projects[EB/OL].(2017-01-30)[2017-09-23] .https://www.ista.org/.
    [7] Chen ZQ,Zhang ZJ,Fu Q.How to choose the correct ISTA procedure[J].Shanghai Packaging(上海包装),2016(12):15-17.
    [8] General Administration of Quality Supervision, Inspection and Quarantine of the People′s Republic of China.GB/T 4857.17-1992Packaging—Transport packages—General principles for the compilation of performance test schedules(包装运输包装件编制性能试验大纲的一般原理)[S].Beijing:Standards Press of China,1992.
    [9] General Administration of Quality Supervision, Inspection and Quarantine of the People′s Republic of China.GB/T 4857.18-1992 Packaging—Transport packages—Quantitative data for the compilation of performance test schedules(包装运输包装件编制性能试验大纲的定量数据)[S].Beijing:Standards Press of China,1992.
    [10] Standardization Administration of the People′s Republic of China.关于批准发布《开槽平端紧定螺钉》等312项国家标准的公告(2017年第18号)[EB/OL].(2017-07-12)[2017-09-23] .http://www.sac.gov.cn/gzfw/ggcx/gjbzgg/201718/.
    [11] American Society for Testing and Materials.Detailed Overview[EB/OL].[2017-09-23] .https://www.astm.org/ABOUT/full_overview.html.
    [12] Daniel AS,Liu F.ASTM international standards and application on medical devices materials and technology[J].J Pharm Anal(药物分析杂志),2010(7):1364-1369.
    [13] Li YL,Liao XM,Min S.ASTM Standards classification and conversion of medical devices[J].Standard Science(标准科学),2014(5):82-86.
    [14] China Aviation Industry Corporation.QJ/T 815.2-94 The simulation acceleration test methods of products in road transportation(产品公路运输加速模拟试验方法)[S].1994.
    [15] American Society for Testing and Materials.D4169-09 Standard Practice for Performance Testing of Shipping Containers and Systems[S].2009.
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  • 刊出日期:  2017-12-24

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