For sensitive sterile pharmaceutical products, or those which require a modified atmosphere in the primary container, Headspace Analysis allows verification of container closure integrity (CCI) as well as monitoring the filling/stoppering process. Loss of container closure integrity can occur due to component defects such as cracks in glass, out-of-specification vial/stopper dimensions or improper vial/stopper combinations. Process issues such as displaced stoppers, misaligned tooling, or rough handling can also affect container integrity.
Headspace analysis also allows for quick and accurate permeation measurements of primary packaging components. Many sterile liquids, powders, freeze dried formulations, and solid dosage products must be protected from reactive gases such as moisture, oxygen, and/or carbon dioxide. The nondestructive nature of the analysis allows permeation monitoring of a single container over time resulting in a very accurate determination of permeation rates.
Another benefit of headspace analysis is that it may be applied to assess leakage that may occur during ultra-cold or cryogenic storage. As a result of storage conditions below the glass-transition temperature of packaging components, the is an increased risk of losing container closure integrity (CCI) under certain conditions. Direct comparison of the container closure system at RT, -20˚C, -80 ˚C, and cryogenic (-178 ˚C) storage is possible.