Laser-Based Headspace Analysis For Parenteral Packages

Assessment of package headspace via laser-based analysis techniques provides a quantitative, nondestructive measure of oxygen, nitrogen, 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.

To be eligible for laser-based headspace analysis, packages need be transparent (colorless) or semi-transparent (amber), as well as possess a minimum headspace volume and headspace path length.  Vials, syringes, cartridges and bottles are all amenable to this approach.

Whitehouse Laboratories operates a “Container Testing Center of Excellence”. The entire business unit brings multiple levels of experience to each container testing program. Staff members with specific areas of expertise are always available to consult on your testing needs.