Objective: To investigate the sensitivity of the microbial ingress test method in container closure integrity detection for injection packaging system. Methods: Two typical rigid and soft injection packaging systems, the borosilicate glass vials and five-layer copolymerized compound membrane infusion bags were selected. The positive samples of defects of different sizes were laser-drilled and penetrated through by planting micro-tubes, respectively, and then subject to the microbial ingress test under a pressure condition. Binary Logistic regression method was used to assess the leakage. Results: Using the simulated conditions of microbial ingress test method established in this study, the detection sensitivity of 2 μm for the vials and 1.5 μm for the infusion bags. Conclusion: Leakage simulation of different injection packaging systems can be achieved by preparing defect positive samples of different sizes with proper approaches and submerged microbial ingress test method is carried out by pressurzing the closed container to simulate an actual transportation condition. Binary Logistic regression statistical analysis can be used to determine the sensitivity of submerged microbial ingress test method in container closure integrity detection for different injection packaging systems, which helps to lay a technical foundation for correlative comparisons with container closure integrity inspection methods for packaging.
WANG Jing, HUANG Si-jia, WANG Ni, ZHANG Fang-fang
. Determination of the container closure integrity for injection packaging via the microbial ingress test method*[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(7)
: 1213
-1220
.
DOI: 10.16155/j.0254-1793.2023.07.15
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