LIGHTHOUSE supports the formulation science of pharmaceuticals by providing broad product and service offerings that can be utilized throughout the entire product lifecycle.
Large molecule biopharmaceuticals are delicate and can be prone to oxidation while dry product needs to be protected from hydrolysis.
Headspace analyzers from LIGHTHOUSE are ideal analytical platforms to investigate formulation stability against oxygen or moisture. The nondestructive nature of the analysis means that valuable product is not destroyed and can be reused for other formulation science activities.
Stability Testing
Understanding a pharmaceutical’s reactivity to oxygen and/or moisture is a critical part of optimizing a product’s shelf life and ensuring its efficacy.
LIGHTHOUSE headspace platforms are specifically designed to check for defects, leaks, or other packaging problems that might compromise a product’s sterility or stability. The rapid nondestructive nature of measurements enable studies involving statistical sample sets, ensuring deeper insight into product stability and enabling the monitoring of a sample over the full shelf life.
Lighthouse Oxygen Monitoring
Oxygen
The headspace gas composition in pharmaceutical product containers is critical if the formulation is oxygen sensitive. Monitoring and controlling headspace oxygen levels throughout the product life cycle becomes necessary to determine accurate stability specifications, monitor nitrogen purging processes during filling, and to assure product stability throughout shelf life.
Laser-based non-destructive headspace oxygen analyzer platforms from LIGHTHOUSE effectively and reliably replace destructive electrochemical and GC methods for determining the oxidation of oxygen sensitive formulations.
Moisture
LIGHTHOUSE understands that residual product moisture content is a critical parameter when considering the stability and shelf life of lyophilized pharmaceutical product, sterile powders, or solid dosage product.
LIGHTHOUSE replaces slow traditional methods with a rapid, non-destructive method that streamlines moisture analysis efforts and helps improve the quality of a finished product. The rapid analytical measurement enables studies using statistical sample sets and the nondestructive nature of the analysis saves valuable product in development activities.
