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Freeze-Drying Microscope Generates Critical Formulation Specific Data


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SP Scientific has video interviewed Dr Kevin Ward of Biopharma Process Systems Ltd, to discuss the key benefits of the Lyostat5 Freeze-Drying Microscope (FDM), and how it can be used to generate critical formulation-specific data.

Every freeze-drying formulation has a critical temperature, below which it should be maintained during primary drying in order to prevent processing defects.

Dr Ward explains how using the Lyostat5 freeze drying microscope allows observation of the sample structure during drying and precise temperature control when cooling or heating so that the exact point of collapse can be determined. In addition, he describes how the Lyostat5 freeze-drying microscope lighting and image capture systems provide sharp visualisation for easy, accurate identification of structural changes. Using the derived data, he explains how after analysis has been carried out that formulations and cycles can be developed that are safe, robust, and cost efficient. Dr Ward summarises that for every 1°C higher a formulation can be freeze dried at, then results in an efficiency saving of 13%.

The Lyostat5 freeze drying microscope is part of the SP Scientific Line of Sight™- enabled suite of freeze drying equipment and technologies portfolio. As well as enabling the determination of critical temperatures including eutectic melting temperature (Teu) and collapse temperature (Tc), the Lyostat5 freeze drying microscope also enables the identification of crystallization phenomena, skin/crust formation, and the effects of annealing on ice crystal growth and solute structure. Knowledge of the critical temperatures is essential to conduct cycle development on a rational, quantitative scientific basis as well as saving precious resources in terms of time and monies needed. The Lyostat5 freeze-drying microscope is supplied fully validated as a complete working system against a series of standard solutions.
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