Package Integrity Test of Glass Ampoules and Its Influencing Factors by High-Voltage Leak Detection Method
Objective To investigate the factors affecting the package integrity of glass ampoules by high-voltage discharge method.Methods The effects of the liquid in the package,ampoule material,ampoule thickness,ampoule appearance,air humidity,and surface moisture of samples on the detection results were analyzed through methodological investigation and influencing factor experiments by using high-voltage discharge method.Results The accuracy of the method was 100％,and the RSDs of repeatability and intermediate precision test results were lower than 10％.The limit of detection(LOD)was 3.573 μm,and the durability was good.In the influencing factor experiment,five kinds of liquid medicine and two kinds of ampoule material(low-borosilicate glass,medium-borosilicate glass)had no significant effect on the detection results,while the thickness,appearance,air humidity,and surface moisture of samples had different degrees of influence on the current value.Conclusion When using high-voltage discharge method for the package integrity test of glass ampoule,attention should be paid to the influence of ampoule thickness,ampoule appearance,air humidity,surface moisture of samples and other factors on the detection results of the current,in order to improve the accuracy of the method.
万方数据
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