HSA Methodology
Assessment of package headspace via laser-based analysis techniques provides a quantitative, nondestructive measure of oxygen, carbon dioxide, water vapor, or internal pressure in a nonporous, rigid or non-rigid package’s headspace. A near-infrared diode laser light is passed through the gas headspace region of the sealed package. Light absorption, measured using frequency-modulated spectroscopy, is indicative of gas concentration and pressure.
As headspace analysis is nondestructive, it may be repeatedly performed over time to provide a quantitative measure of a sample’s leak rate. This technology is especially applicable when verifying the integrity of packages that must maintain a specific gas headspace content due to oxygen or moisture sensitive product, for example. Additionally, this technology 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
Defects
DDL utilizes our approved vendor to fabricate laser-drilled defects at particular locations throughout a package system (ref. figure on right). Each one of these “Positive Controls” come with a certificate of calibration to not only increase traceability, but also to validate a method to a confident Limit of Detection.
Timeline
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