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Medical Package Testing

This test method will detect and locate a leak in package edge seals formed between a transparent film and a porous sheet material.

Harmful biological or particulate contaminants may enter the device through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials. Leaks may also result from a pinhole in the packaging material. This dye penetrant procedure is applicable only to individual leaks in a package seal. The presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated.

There is no general agreement concerning the level of leakage that is likely to be deleterious to a particular package. However, since these tests are designed to detect leakage, components that exhibit any indication of leakage are normally rejected.Since leaks may change in size with different ambient conditions, comparisons between test stations are not conclusive. Therefore this method is usually employed as a go, no-go test. The dye solution will wick through any porous material over time, but usually not within the maximum time suggested. If wicking does occur, it may be verified by observing the porous side of the subject seal area. The dye will have discolored the surface of the material.