The Role of In-Line Image Analysis in the Transition to Continuous Manufacturing in the Pharmaceutical Industry
Javier Cardona, Carla Ferreira, Vaclav Svoboda, Bilal Ahmed, John McGinty, Okfpeafoh S. Agimelen, Andrew Hamilton, Alison Cleary, Robert Atkinson, Craig Michie, Stephen Marshall, Alastair J. Florence, Yi-Chieh Chen, Jan Sefcik, Ivan Andonovic, Christos Tachtatzis
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 real-time 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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