Standard Deliberation

Correlation analysis of mass extraction method and microbiological ingress method for determination of package integrity of injection vials for drug packaging*

Expand
  • Shanghai Food and Drug Packaging Material Control Center, Shanghai 201203, China

Revised date: 2023-08-08

  Online published: 2024-06-21

Abstract

Objective: To establish a correlation between mass extraction method and microbial ingress method in testing the package integrity of vial packaging system. Methods: The mass extraction method used different laser-driven micro-holes samples to test the linearity, the positive rate sensitivity and the limit of quantitation. In microbiological expression method, the treated laser-drilled micro-holes samples were immersed upside down into the suspension of Pseudomonas aeruginosa. After pressurization and immersion, the samples were taken out and cultured. Results: The sensitivity of mass extraction method was better than that of microbial challenge method. The positive rate sensitivity of the mass extraction method was 0.2 μm, and the positive rate sensitivity of the microbial ingress method was 0.3 μm. The mass flow of the vial sample with 3 μm microhole was 19.1 μg·min-1. The correlation coefficient between mass flow and positive probability of microbial ingress were 0.98. Conclusion: The correlation analysis method established in this paper could effectively test the package integrity of the vials.

Cite this article

ZHANG Fang-fang, XIAN Fu-rong, YAO Lin . Correlation analysis of mass extraction method and microbiological ingress method for determination of package integrity of injection vials for drug packaging*[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(11) : 1920 -1924 . DOI: 10.16155/j.0254-1793.2023.11.15

References

[1] 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 [2022-02-09]. https://www.cde. org. cn/main/news/viewInfoCommon/8a4f9f16844fbed617f8e8ed59485c1d
Center for Drug Evaluation,NMPA. Guideline to container-closure integrity test for chemical injections (Trial) [EB/OL]. 2020[2022-02-09]. https://www.cde. org. cn/main/news/viewInfoCommon/8a4f9f16844fbed617f8e8ed59485c1d
[2] 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
GUO DL, DONG WJ, MA JW, et al. Introduction and interpretation of USP <1207> package integrity evaluation for sterile products[J]. Chin J New Drug, 2021, 30(10): 880
[3] 国家药典委员会. 欧美日药典药包材标准选编[M]. 北京:化学工业出版社,2019:200
Chinese Pharmacopoeia Commission. Selections of Pharmaccutical Packing Materials Standards from EP,USP and JP[M]. Beijing:Chemical Industry Press, 2019:200
[4] 马骏威,郭涤亮,刘涓,等. 胶塞/玻璃瓶容器密封完整性研究的探讨[J]. 中国新药杂志,2021,30(5):394
MA JW, GUO DL, LIU J, et al. Discussion on the container closure integrity of rubber stopper/glass container[J]. Chin J New Drug, 2021,30(5):394
[5] 王冬伟,张博,张翔,等. 无菌药品包装系统密封完整性研究焦点问题的分析[J]. 中国药事,2022,36(2):133
WANG DW, ZHANG B,ZHANG X, et al. Analysis on the key points of container-closure integrity for sterile product packaging systems[J]. Chin Pharm Aff, 2022, 36(2):133
[6] American Society of Testing Materials. ASTM E3251-20 Standard Test Method for Microbial Ingress Testing on Single-Use Systems[S]. 2017
[7] 陈江,王俊苏,关天横,等. 注射剂包装密封完整性检测技术研究进展[J]. 中国药业,2021,30(2):5
CHEN J, WANG JS,GUAN TH, et al. Research progress of container closure integrity test of injections[J]. China Pharm, 2021, 30(2):5
[8] American Society of Testing Materials. ASTM F3287-17 Standard Test Method for Nondestructive Detection of Leaks in Packages by Mass Extraction Method[S]. 2017
[9] YOON SY,SAGI H,GOLDHAMMER C, et al. Mass extraction container closure integrity physical testing method development for parenteral container closure systems[J]. PDA J Pharm Sci Technol,2012,66(5):403
[10] 姚琳,咸富荣,张芳芳. 质量提取法测试西林瓶包装系统密封性[J]. 中国医药工业杂志,2022,53(7):1013
YAO L, XIAN FR,ZHANG FF. Mass extraction method for the package integrity testing of vials[J]. Chin J Pharm, 2022, 53(7):1013
[11] 王冬伟,张磊,张祥龙,等. 真空衰减法测试西林瓶药品包装的密封完整性[J]. 中国药事,2020,34(5):589
WANG DW, ZHANGN L, ZHANG XL, et al. Vacuum decay method for the closure integrity testing of injection vials[J]. Chin Pharm Aff, 2020, 34(5):589
[12] 王妮,黄思嘉,王静,等. 注射剂瓶容器密封完整性:微生物挑战法与色水法的关联比较分析[J]. 中国医药工业杂志,2022,53(2):246
WANG N, HUANG SJ, WANG J, et al. Integrity of sealed injection bottle container:correlation and comparative analysis of microbiologic[J]. Chin J Pharm, 2022, 53(2):246
[13] 许凯. 无菌药品包装密封完整性验证研究[J]. 科技与企业,2013(23):416
XU K. Study on validation of package integrity of sterile drug[J]. Sci Technol Enterprise, 2013(23):416
[14] 柯茂琴,张新. 注射剂容器密封系统完整性研究[J]. 亚太传统医药,2010,56(4):154
KE MQ,ZHANG X. Research on the integrity of the container closure system[J]. Asia Pac Tradit Med, 2010, 56(4):154
[15] 封二飞,张筱宜,赵明. 无菌药品容器密封完整性检测方法对比研究[J]. 中国药业,2021,537(14):51
FENG EF, ZHANG XY, ZHAO M. Comparative study on the methods of the sterile drug container-closure integrity test[J]. China Pharm, 2021, 537(14):51
[16] 林燕,张宝献,刘春兰,等. 实验室几种常用菌悬液制备方法的探讨[J]. 广东化工,2021,455(21):65
LIN Y, ZHANG BX, LIU CL, et al. Comparative study on the methods of the sterile drug container-closure integrity test[J]. Guangdong Chem Ind, 2021, 455(21):65
[17] ALIASKARISOHI S, HOGREVE M, LANGLOIS C, et al. Single-use system integrity Ⅰ: using a microbial ingress test method to determine the maximum allowable leakage limit (MALL)[J]. PDA J Pharm Sci Technol, 2019, 73(5):459
[18] 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 J Pharm Sci Technol, 2007, 61(4):226
[19] NGUYEN LT,MUANGSIRI W,SCHIERE RR, et al. Pharmaceutical container/closure integrity. Ⅳ: Development of an indirect correlation between vacuum decay leak measurement and microbial ingress[J]. PDA J Pharm Sci Technol, 1999, 53(4):211
[20] 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 J Pharm Sci Technol, 2000, 54(6):449
[21] 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
LU WY, CAI R, et al. Study on sealing integrity of drug packaging system at home and abroad and consideration on ensuring[J]. Chin Pharm Aff, 2021, 35(7):828
[22] 杨梦雨,赵霞,孙会敏. 无菌制剂容器密封完整性检测技术和相关法规研究进展[J]. 中国新药杂志,2022,31(3):245
YANG MY, ZHAO X, SUN HM, et al. Research progress on container-closure integrity regulations and detection technology aseptic preparation[J]. Chin J New Drug, 2022, 31(3):245
Outlines

/