THE PROBLEM:

A pharmaceutical company was concerned when streaks began appearing on vial caps, making them unusable (Figure 1). This problem put the manufacturer at risk of not fulfilling contracted orders, and they needed to identify the foreign material responsible for the streaking immediately. That’s when MVA Scientific Consultants became involved.

THE ANALYSIS:

Upon arrival at MVA, the caps were inspected using a stereomicroscope, and the streaks were obvious. The streaked caps were then analyzed by scanning electron microscopy with energy dispersive x-ray spectroscopy (SEM/EDS). The streaks were found to be comprised of micrometer sized aluminum particles (Figure 2). The aluminum particles were not easily rubbed from the surface of the cap and they did not appear to be abrasion or wear particles. Rather, they seemed to be a fine dust deposited on the caps.

THE OUTCOME:

The location and nature of the streaks suggested the aluminum particles were transferred to the caps from another surface, such as a processing equipment component that holds the neck of the vials and caps during the final capping stage. MVA Scientific Consultants’ analytical results enabled the pharmaceutical manufacturer to trace the contamination back to equipment in the production line that was responsible for depositing the aluminum streaks.