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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

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

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  • 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.
  • [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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