What are the common crimp, cap and stopper sealing defects in injectables?

Crimp, cap and stopper defects are failures of the aluminium seal, flip-off cap or rubber stopper that closes the vial. They include scored, dented, gouged, scalloped, cut and malformed aluminium crimps, blemishes on the flip-off seal, spots on the stopper, and stopper non-sealing-surface defects.

The aluminium crimp and seal defects are a family in themselves: a completely scored aluminium crimp, a malformed or severely dented crimp, a dented or gouged crimp, a scalloping or pinched crimp (a single pinch or wrinkle), a cut aluminium crimp (a small slit in the lower skirt), a knurling defect (a damaged, incomplete or irregular knurl on the seal edge), a dented collar, and a bruised seal (an impact mark on the aluminium seal). Each affects the seal's integrity or appearance and is graded against a limit sample held in the defect library. A blemish on the flip-off seal is a mark or flaw on the flip-off button.

On the closure itself, a spot on the stopper and stopper non-sealing-surface defects --- scratches, pits, blisters or dents on the non-sealing area --- are graded separately from defects on the critical sealing surface, which bear directly on container closure integrity.

FTI builds crimp, cap and stopper defect units into its challenge sets and limit-sample libraries so inspectors are qualified against real closure defects, and its CCIT challenge kits and laser-drilled positive controls verify that the seal failures affecting integrity are actually caught.