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

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: Lyophilization; Optimization; Dynamic modeling; Glass transition temperature

Domains: Chemical and Process Engineering; Galenic pharmacology

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, 2007, 25 (5), pp.741-751. ⟨10.1080/07373930701370100⟩. ⟨hal-01537101⟩