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.