Objective:To establish high-voltage leak detection and microbiological challenge test(microbial ingress method)to determine the package integrity of the injection vial.Methods:The package integrity of the injection vial was determined using the high-voltage leak detection and microbiological challenge test(microbial ingress method).Results:The positive detection rates of 1,3,5 and 10 μm laser-bored hole samples were 0%,30%,60%and 70%by microbiological challenge test(microbial ingress method),respectively and 100%by high-voltage leak detection method.The sensitivity of positive rate was 1.4 μm by the microbial ingress method,and 1 μm by the high-voltage leak detection,and the later was higher than the former.Conclusion:Both the high-voltage leak detection and microbiological challenge test(microbial ingress method)can be used to evaluate the container closure integrity of injection vials.
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