Application of multivariate image analysis for on-line monitoring of a freeze-drying process for pharmaceutical products in vials

• DOI: 10.1016/j.chemolab.2019.02.004
• Publication Date: 2019-02-13T11:29:17Z
• Authors: Domenico Colucci; José M. Prats-Mon...; Davide Fissore; Alberto Ferrer
• Keywords: Process Analytical Technology; Imputation (statistics); Line (geometry)

[EN] A new Process Analytical Technology (PAT) has been developed and tested for on-line process monitoring of a vacuum freeze-drying process. The sensor uses an infrared camera to obtain thermal images of the ongoing process and multivariate image analysis (MIA) to extract the information. A reference model was built and different kind of anomalous events were simulated to test the capacity of the system to promptly identify them. Two different data structures and two different algorithms for the imputation of the missing information have been tested and compared. Results show that the MIA-based PAT system is able to efficiently detect on-line undesired events occurring during the vacuum freeze-drying process.<br/>The authors would like to acknowledge Elena Lietta for her support in the experimental investigation. This research work was partially supported by the Spanish Ministry of Economy, Industry and Competitiveness under the project DPI2017-82896-C2-1-R.<br/>