Poster: Non-destructive headspace moisture detection for lyo cycle optimization and 100% moisture inspection of the finished product
This poster describes the application of Frequency Modulation Spectroscopy (FMS) for optimization of a commercial freeze-drying cycle and for rapid 100% inspection of the finished lyo product.
FMS headspace moisture inspection is a rapid and non-destructive technique that simultaneously determines the water vapor and vacuum levels inside a vial. The determination of water vapor levels (water activity) as a quality control assessment is standard in the food industry and is now being applied in the pharmaceutical industry.
Standard moisture analysis methods used in the pharmaceutical industry, namely Karl Fischer titration (KF) and thermo-gravimetric analysis (TGA), do not distinguish between ‘active’ water that is detrimental to product stability and ‘bound’ water that cannot chemically interact with the active ingredient and excipients. From a practical point of view, the KF and TGA methods are time consuming, sometimes unreliable, and ultimately result in the destruction of the sample. A headspace water vapor measurement solves these issues.
It has been demonstrated that headspace moisture correlates to KF measurements and can also be directly correlated to product stability. Water vapor in the headspace is a measure of the active water available to chemically interact with the active ingredient and excipients.
Please download the poster to read how a manufacturer of freeze-dried drug Product, used headspace moisture inspection to:
1) Optimize the efficiency of a commercial lyo cycle, 2) Identify out-of-specification samples that were not sufficiently dried, and 3) Identify vials that had lost closure resulting in loss of vacuum.
Download the Application Note “Stopper Pop-Up and the Effects on Container Closure of Sterile Vials” Download the Application Note “In-process Monitoring of Headspace Oxygen Levels in Parenteral Containers" |
