Abstract

The concentration of H2O and the pressure in the headspace of vials are simultaneously measured by a tunable diode laser sensor based on absorption spectroscopy techniques. The 7168.437cm−1 spectral line of H2O is chosen as the sensing transition for its strong absorption strength and being reasonably far away from its neighboring molecular transitions. In order to prevent interference absorption by ambient water vapor in the room air, a difference between the measured signal and the referenced signal is used to calculate the pressure and H2O concentration in the headspace of vials, eliminating the need for inert gas purges and calibration with known gas. The validation of the sensor is conducted in a static vial, yielding an accuracy of 1.23% for pressure and 3.81% for H2O concentration. The sensitivity of the sensor is estimated to be about 2.5Torr for pressure and 400ppm for H2O concentration over a 3cm absorption path length respectively. Accurate measurements for commercial freeze-dried products demonstrate the in-line applications of the sensor for the pharmaceutical industry.

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