How are cracks and broken containers detected in visual inspection?
Cracks and breakage are container-integrity defects detected during visual inspection. They include cracked components, chipped or broken glass, glass flakes, and glass delamination (lamellae).
These are critical defects because a crack or breach compromises container closure integrity and sterility. A cracked component may be a hairline fracture in the vial wall, neck, or base; glass flakes are small fragments that can shed into the solution; and glass delamination is the formation of thin glass lamellae peeling from the inner surface under certain pH, formulation, and storage conditions. Cracks are often hardest to see at the container base and neck, so inspection and challenge-set design give these areas special attention.
FTI's challenge sets include cracked-component units, and its analytical team supports glass delamination analysis and container characterization when breakage or lamellae are found in production. Cracks link directly to container closure integrity testing (CCIT), where FTI supplies laser-drilled positive-control standards.
