Through Vial Impedance Spectroscopy (TVIS): A new method for the development of manufacturing processes for inject-able drug products.10th International Workshop on Impedance Spectroscopy; 2017 Sept 28-29; Chemnitz, Germany.

Abstract

cite as: Smith, G. (2017) Through Vial Impedance Spectroscopy (TVIS):A new method for the development of manufacturing processes for inject-able drug products. Podium presentation at 10th International Workshop on Impedance Spectroscopy; Sept 28-29; Chemnitz, Germany. Presentation Overview: - Introduction to TVIS (i) equations for the derivation of complex capacitance from the measured impedance, (ii) a simplified equivalent circuit model for the observed relaxation process; (iii) example impedance spectra and the equivalent capacitance spectra for the TVIS vial with a 5% w/v solution of lactose in the liquid and frozen states and empty- Applications for TVIS (i) calibration of TVIS parameter FPEAK for the temperature of the ice and the subsequent application of the derived parameter T(FPEAK) in the prediction of the temperature of ice during the primary drying stages; (ii) use of temperature compensated value for the height of the dielectric loss peak (CPEAK) for the determination of the ice sublimation rate.