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Deconstructing The Blue Dye Leak Test Method

Source: PTI Packaging and Inspection Systems

By Oliver Stauffer, PTI Packaging and Inspection Systems

Blister package manufacturing for tablets and capsules has process and material parameters that are unique to each product. Barrier properties of blister packaging are primarily designed to eliminate moisture ingress, a result of H2O molecules passing through micro leaks over extended periods of time.

Moisture ingress into blister packaging is best measured and evaluated by conducting a desiccant weight gain study. Past desiccant weight gain studies have shown that significant moisture ingress begins to occur with pin hole defects of 15µm and greater. However, results vary based on a variety of package, product, and environmental variables.