Moisture Determination of Dry product
Residual product moisture content is a critical parameter when considering the efficacy and shelf life of lyophilized pharmaceutical product, sterile powders, or solid dosage product. Moisture analysis is traditionally performed using Karl Fischer titration or thermo-gravimetric analysis (TGA) methods, which are not only destructive but also labor & time intensive.
Lighthouse offers solutions for moisture determination based on rapid nondestructive laser-based headspace analysis. Replacing the traditional destructive methods will enable the generation of robust science-based moisture data and will help improve process and product quality.
Moisture determination Solutions:
Moisture stability studies
Dry pharmaceutical product needs to be protected from moisture to achieve an optimal efficacy and shelf life. Stability studies have shown that the degradation of the active pharmaceutical ingredient correlates to the initial water vapor concentration present in the freeze-dried vial. Therefore, sterile injectable products such as freeze-dried formulations or dry powders are often sealed in stoppered vials under dry nitrogen. However, over the shelf life of the product it is possible for moisture to permeate into the vial. This can be measured with laser-based headspace analysis. Stability studies using this method indicate that rapid water vapor determination with an optical method could replace the slow destructive traditional methods for the moisture analysis of freeze-dried product.
Freeze Drying Process Development & Validation
Moisture analysis performed using Karl Fischer titration or thermo-gravimetric analysis (TGA) methods is slow and destructive and not useful for monitoring freeze drying (lyophilization) processes. Rapid non-destructive laser-based headspace moisture analysis allows for statistical sampling or 100% real-time moisture inspection. Using an inspection platform for 100% headspace moisture analysis of lyo product batches gives full insight into final product quality variability, which in turn enables efficient cycle development and optimization and freeze dryer qualification. Industry applications include freeze drying cycle optimization, lyo chamber moisture distribution mapping and moisture headspace analysis for efficient scale-up of freeze-drying capacity.
100% moisture inspection of commercial freeze-dried product
Non-destructive headspace moisture analysis allows for statistical sampling or 100% inspection of headspace moisture levels for product with a moisture specification. The non-destructive nature of the measurement ensures that no valuable product is lost. In addition, performing headspace moisture analysis on packaging lines just before labeling ensures that no out of specification product is released to the market.