CONTAINER CLOSURE INTEGRITY
LASER-BASED HEADSPACE ANALYSIS (HSA)
HSA or Headspace Analysis, is a deterministic, non-destructive leak detection method to evaluate vials, syringes, cartridges and other parenteral products.
Oxygen concentration/partial pressure, carbon dioxide concentration/partial pressure, or total pressure conditions inside a container can be measured over time. When sample testing is performed over time, a quantitative measure of a container closure system’s (CCS) leak rate can be determined. The headspace analysis technology operates by passing a near-infrared diode laser light through the gas headspace region of the sealed container. Light absorption, measured using frequency-modulated spectroscopy, is indicative of gas concentration. Transparent or amber vials, syringes, and cartridges with a minimum headspace volume and headspace path length can be tested using an appropriate test fixture.
Laser absorption spectroscopy method for headspace gas analysis enables robust characterization of the primary packaging of sterile pharmaceutical drug products. This technology is especially applicable when verifying the inherent integrity of container closure systems that must maintain a specific gas headspace content due to oxygen or moisture sensitive product.
Applications of Headspace Analysis
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.
The scientists at ZebraSCI are experienced in applying headspace analysis to your primary packaging challenges and are here to help.
Contact ZebraSci today to learn more about applications for HSA and our other solutions for Container Closure Integrity.