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Advancing Pharmaceutical Stability with Strain Gauges at LyoHUB

Strain gauges are typically used to measure deformation or strain on an object. At the LyoHUB Demonstration Facility, thin film micromachined sensing elements are strategically placed on vials during the freeze-drying process to monitor the mechanical stresses that occur during the freezing, thawing, and drying phases. The data collected helps in understanding how different materials and formulations react under stress, which can potentially influence the quality and stability of freeze-dried pharmaceutical products. It also helps users understand the effects of vial breakage with respect to the formulation and freezing protocols. This information allows new cycles to be designed that mitigate this unwanted behavior.

The introduction of strain gauges into the lyophilization process represents a significant technological leap. By integrating these sensors, researchers can collect precise data on how vials deform under various conditions, which directly influences the quality of the final product. For instance, some recent LyoHUB experiments have utilized strain gauges to measure the effects of different freezing rates and compositions, revealing valuable insights into the optimization of the lyophilization cycle. As the LyoHUB facility continues to evolve, the use of strain gauges represents just one of the many innovations being explored. The ongoing research not only contributes to the scientific community but also has practical implications for the pharmaceutical industry.

Figure 1: Image of gauged vial used to characterize thermomechanical response of borosilicate vials during freezing and thawing

 

Figure 2: Measured gauge output during freezing and thawing for different concentrations of sucrose (%w/v unless indicated). The strain response varies with concentration and temperature.