Visual Inspection Test

This ASTM visual inspection method is a non-destructive visual examination of a sterile barrier closure seal to identify any potential seal defects, such as channels, wrinkles, folds, voids, or other visually-evident defects of the sterile barrier. The method is applicable to both flexible and rigid packages with a minimum of one transparent side so that the seal is in plain view. The effectiveness depends on factors such as the size of the channel, the materials used in the packaging, whether or not magnification is used, type of adhesion used, and the visible contrast between sealed and unsealed areas.

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Industry Application

Visual inspection for sterile barrier integrity is an important feature of all packaging validation activities – including process validation, transit validation, and shelf life validation. It would be conducted alongside other package and seal integrity tests, such as dye leak testing, bubble leak testing, or seal strength testing. Visual inspection is also routinely incorporated into production processes as a 100% visual inspection of each sealed package immediately after the sealing operation and before the packaged products are introduced to cartons or boxes.