The role of in-line image analysis in the transition to continuous manufacturing in the pharmaceutical industry

Cardona, Javier and Ferreira, Carla and Svoboda, Vaclav and Ahmed, Bilal and McGinty, John and Agimelen, Okpeafoh S. and Hamilton, Andrew and Cleary, Alison and Atkinson, Robert and Michie, Craig and Marshall, Stephen and Florence, Alastair J. and Chen, Yi-Chieh and Sefcik, Jan and Andonovic, Ivan and Tachtatzis, Christos; Thorvald, Peter and Case, Keith, eds. (2018) The role of in-line image analysis in the transition to continuous manufacturing in the pharmaceutical industry. In: Advances in Manufacturing Technology XXXII. Advances in Transdisciplinary Engineering . IOS Press, SWE, pp. 27-32. ISBN 978-1-61499-901-0 (https://doi.org/10.3233/978-1-61499-902-7-27)

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Abstract

In recent years, the pharmaceutical industry is seeing a movement towards the implementation of more efficient continuous manufacturing. This shift requires the development of in-line process analytical technologies to monitor and control the process at any given time. However, extracting reliable information from these sensors is a challenge. Among the available technologies, in-line image analysis is quickly gaining importance. This work presents an image analysis framework developed to address one of the main challenges of in-line image analysis: the presence of out-of-focus particles. Through two relevant examples such as the characterisation of a system of microparticles of mixed shapes and the monitoring of a common operation in the pharmaceutical industry such as the wet milling process, the benefits of incorporating this technique are assessed. The realtime analysis of imaging data in combination with other simultaneously-acquired quantitative data streams enables the user to make informed decisions and implement enhanced control strategies.

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