The characterization, porosity, permeability and integrity of conductive and non-conductive medical and consumer flexible barrier packaging material are determined utilizing a novel electron beam technology and electronic instrumentation in an open atmosphere for 100% real-time, on-line testing. The electron beam developed in an open atmosphere maintains its prescribed frequency through the use of a nitrogen cover gas, ionizing the gas to create a corona beam. The corona beam discharge, maintained at a high negative voltage, forms from the holes or anomalies in the flexible barrier material. The anomaly is detected and analyzed in order to determine the presence of viral and sub-viral sized voids or holes, as well as other anomalies such as blisters and bubbles. The process can also utilize an established range of acceptability to certify materials that require a well defined level of permeability. This process can be performed by the flexible barrier film manufacturer to certify a specific quality level. It can be performed by the material fabricator to ensure quality standards for preformed materials. It can also be performed by the product packaging manufacturer that uses the packaging material to wrap their products and confirm the integrity of the final sealed package by measuring the atmosphere inside the finished package. There are many other packaging applications that can utilize this technology for film characterization, validation and integrity testing within the pharmaceutical, medical device, and food processing industries, as well as other industrial applications.
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