Several glass vials with white contents and red caps are arranged on a white surface in a well-lit laboratory setting.

Headspace moisture determination

Residual moisture content is a critical parameter when considering the efficacy and shelf life of lyophilized pharmaceutical product, sterile powders, or solid dosage product. With headspace moisture analysis 100% of products can be inspected, providing complete data-driven insight into freeze drying process efficiency and consistency.

Analyzing residual moisture content with headspace analysis is….

  • Rapid and non-destructive
  • Capable of providing deep insight into efficiency of freeze drying processes
  • Possible on 100% of the samples
  • Preventing release of out of specification product

Residual moisture content is a critical parameter when considering the efficacy and shelf life of lyophilized pharmaceutical product. To specify and control the maximum allowable moisture content, analysis is carried out in product and process development as well as in commercial manufacturing.

Traditionally moisture content is determined using Karl Fischer titration or thermo-gravimetric analysis – which are not only destructive but also time and labor intensive methods. LIGHTHOUSE headspace moisture determination replaces these traditional destructive methods, to generate more and better data, faster. 

 

Four small glass vials are placed on a white surface next to a machine labeled

Prevent product degradation from moisture through robust package development and stability studies

To prevent moisture degradation, dry pharmaceutical products are sealed under an atmosphere of dry nitrogen or air. However, over the shelf life of the product moisture will permeate into the vial. The rate at which this happens can be monitored during stability using non-destructive headspace moisture analysis. In addition, package development studies can be carried out using the same technology to determine the best possible package components for your product. 

 

Several clear glass vials with red caps partially filled with a white substance are arranged on a white surface with a blurred background, highlighting the importance of Container Closure Integrity Testing.

Optimize your freeze drying process with 100% moisture mapping

Residual moisture levels of dry pharmaceutical products can vary based on the location of the vial inside a freeze dryer. With headspace moisture analysis “wet spots” inside the freeze drier can be identified throughout a lyophilization chamber – on 100% of the samples. This can then be used to optimize freeze drying cycles to obtain a homogenous moisture distribution. Improve your product quality and manufacturing efficiency by eliminating ‘wet spots’ and preventing overdrying of your product.

 

A close-up view of an automated machine with multiple circular trays, each holding numerous small vials, arranged for laboratory processing or testing.

Ensure that no out-of-specification product is released

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. More importantly, performing headspace moisture analysis on packaging lines just before labeling ensures that no out of specification product is released to the market.