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In a freeze-drying process for pharmaceuticals it is necessary to monitor product temperature and to identify the ending point of the ice sublimation stage. Besides, it can be worthwhile estimating the heat and mass transfer coefficients, in such a way that a mathematical model can be used to optimize in-line (or off-line, in a successive run) the process. Both results can be achieved using the temperature...
This paper is focused on the Pressure Rise Test method that is commonly used to monitor a freeze-drying cycle. Its performances seemed to be dependent on processing conditions and/or batch and equipment size. Here, we demonstrate that this behavior was linked to the response of the pressure sensor, which is commonly neglected by all the algorithms proposed in literature. An update of these algorithm,...
This paper describes the development and characterization of thermocouples with nanometric thickness made inert by means of a glass-like coating. These thermocouples are designed to follow the freeze-drying process of pharmaceutical products without perturbing freezing and drying steps but can be used in several other applications where the perturbation introduced by wire thermocouples can prevent...
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