Objective: To analyze the key problems existing in the research on the container-closure integrity for the domestic sterile pharmaceutical packing system, so as to provide suggestions for solving the problems and useful references for the related researches. Methods: Domestic and foreign regulations and standard requirements were compared, the meaning and application of key concepts in the research on container-closure integrity of sterile pharmaceutical packaging systems were investigated and analyzed in depth; relevant literature and practical experience was consulted and researched, the examples on solving the key problems of containerclosure integrity were summarized and analyzed; the current research status of the container-closure integrity of the pharmaceutical packaging system in China was combined, and a flow chart of the container-closure integrity of the pharmaceutical packaging system was drawn. Results and Conclusion: The research on the containerclosure integrity of the sterile pharmaceutical packaging system is a complex and systematic work, and it is in the premise of the accurate understanding and analysis of the key issues. The drawing of the container-closure integrity research flow chart could simplify and facilitate the development of the research.
Wang Dongwei, Zhang Bo, Zhang Xiang, Xiong Wei, Li Wenli, Han Naishui, Zhang Jing
. Analysis on the Key Points of Container-Closure Integrity for Sterile Product Packaging Systems[J]. Chinese Pharmaceutical Affairs, 2022
, 36(2)
: 133
-138
.
DOI: 10.16153/j.1002-7777.2022.02.003
[1] 国家药品监督管理局药品审评中心.化学药品注射剂仿制药质量和疗效一致性评价技术要求[EB/OL].(2020-05-14)[2021-02-22].http://www.cde.org.cn/news.do?me thod=largeInfo&id=273fc1d71980a553.
[2] 国家药品监督管理局药品审评中心.化学药品注射剂包装系统密封性研究技术指南(试行)[EB/OL].(2020-10-21)[2021-02-22].http://www.cde.org.cn/news.do?me thod=largeInfo&id=25e20e27564a85cf.
[3] FDA.Guidance Documents:Container Closure Systems for Packaging Human Drugs and Biologics[EB/OL].(1999-05)[2021-02-22].https://www.fda.gov/regulatory information/search-fda-guidance-documents/container closure-systems-packaging-human-drugs-and biologics.
[4] Technical Report No.27 Pharmaceutical Packaging Integrity[J].PDA Journal of Pharmaceutical Science and Technology,1998,52(4):112.
[5] The United States Pharmacopieial Convention.United States Pharmacopeia 43 General Chapter 1207 Package Integrity Evaluation—Sterile Products[S].2020.
[6] The United States Pharmacopieial Convention.United States Pharmacopeia 43 General Chapter 1207.1 Package Testingin the Product Life Cycle-test Method Selection and Validation[S].2020.
[7] The United States Pharmacopieial Convention.United States Pharmacopeia 43 General Chapter 1207.2 Package Integrity Leak Test Technologies[S].2020.
[8] The United States Pharmacopieial Convention.United States Pharmacopeia 43 General Chapter 1207.3 Package Seal Quality Test Technologies[S].2020.
[9] Parentral Drug Association.Technical Report No.86 Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing [S].2021.
[10] Kirsch LE,Nguyen L,Moeckly CS,et al.Pharmaceutical Container Closure Integrity II:The Relationship Between Microbial Ingress and Helium Leak Rates in RubberStoppered Glass Vials[J].PDA Journal of Pharmaceutical Science and Technology,1997,51(5):195-202.
[11] Burrell LS,Carver MW,Demuth GE,et al.Development of a Dye Ingress Method to Assess Container-Closure Integrity:Correlation to Microbial Ingress[J].PDA Journal of Pharmaceutical Science and Technology,2000,54(6):449-455.
[12] Aliaskarisohi S,Hogreve M,Langlois C,et al.SingleUse System Integrity I:Using a Microbial Ingress Test Method to Determine the Maximum Allowable Leakage Limit(MALL)[J].PDA Journal of Pharmaceutical Science and Technology,2019,73(5):459-469.
[13] Morrical BD,Goverde M,Grausse J,et al.Leak Testing in Parenteral Packaging:Establishment of Direct Correlation between Helium Leak Rate Measurements and Microbial Ingress for Two Different Leak Types [J].PDA Journal of Pharmaceutical Science and Technology,2007,61(4):226-236.
[14] 郭涤亮,董武军,马骏威,等.《美国药典》＜1207＞无菌药品包装系统密封性评估的介绍与解读[J].中国新药杂志,2021,30(10):880-885.
[15] 陆维怡,蔡荣.国内外药品包装系统密封完整性研究与保障药品质量安全的思考[J].中国药事,2021,35(7),828-834.
[16] 封二飞.无菌药品包装完整性研究[J].中国医药工业杂志,2019,50(11):1352-1357.
