For sterile medical devices, it’s critical that the seal on the package be completely intact to maintain product sterility. Seal defects can include voids, wrinkles, dust, random particles, or hair—all of which threaten the integrity of the seal. Inspecting seals after they’ve been formed has traditionally been a manual, visual process, done on a sample basis. Destructive package integrity testing may also be used, but this results in the package being discarded and the contents being rehandled on the production line for repackaging.
When producing Class III medical devices, a sampling strategy leaves room for failures to escape into the field, since the samples qualify an entire lot, rather than a specific item. Manual inspection can also be unreliable: humans get tired, get distracted, or get confused with borderline defects. As a result, lots that should be reworked might end up being shipped instead.
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