An Interactive Tool for the Optimization of Freeze-Drying Cycles Based on Quality Criteria

Ioan-Cristian Trelea 1 Stéphanie Passot 1 Fernanda Fonseca 1 Michele Marin 1
1 GMPA - Génie et Microbiologie des Procédés Alimentaires
Abstract : Among existing dehydration methods, freeze-drying has unique benefits for the stabilization and preservation of biological activity of pharmaceutical products but remains an expensive and time-consuming process. A user-friendly software tool was developed, allowing for interactive selection of process operating condition profiles in order to maximize process productivity while insuring product quality preservation. The software is based on a dynamic, one-dimensional heat and mass transfer model, which can accurately represent both the primary and secondary drying stages and the gradual transition between them. The model was validated in a wide range of operating conditions: − 25 to + 25°C shelf temperature and 10 to 34 Pa total pressure. By comparing a reference sucrose solution with a formulated pharmaceutical product containing polyvinylpyrrolidone (PVP), it is shown that controlling product properties such as glass transition temperature and sorption isotherm can reduce the minimum achievable cycle duration by 12 h (33%).
Keywords : Glass transition temperature Dynamic modeling Lyophilization Optimization
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Ioan-Cristian Trelea, Stéphanie Passot, Fernanda Fonseca, Michele Marin. An Interactive Tool for the Optimization of Freeze-Drying Cycles Based on Quality Criteria. Drying Technology, Taylor & Francis, 2007, 25 (5), pp.741-751. ⟨10.1080/07373930701370100⟩. ⟨hal-01537101⟩

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