Using Mathematical Modeling and Prior Knowledge for QbD in Freeze-Drying Processes

Author(s):  
Davide Fissore ◽  
Roberto Pisano ◽  
Antonello A. Barresi
2012 ◽  
Vol 48 (2) ◽  
pp. 203-209 ◽  
Author(s):  
Camila Figueiredo Borgognoni ◽  
Joyce da Silva Bevilacqua ◽  
Ronaldo Nogueira de Moraes Pitombo

Transplantation brings hope for many patients. A multidisciplinary approach on this field aims at creating biologically functional tissues to be used as implants and prostheses. The freeze-drying process allows the fundamental properties of these materials to be preserved, making future manipulation and storage easier. Optimizing a freeze-drying cycle is of great importance since it aims at reducing process costs while increasing product quality of this time-and-energy-consuming process. Mathematical modeling comes as a tool to help a better understanding of the process variables behavior and consequently it helps optimization studies. Freeze-drying microscopy is a technique usually applied to determine critical temperatures of liquid formulations. It has been used in this work to determine the sublimation rates of a biological tissue freeze-drying. The sublimation rates were measured from the speed of the moving interface between the dried and the frozen layer under 21.33, 42.66 and 63.99 Pa. The studied variables were used in a theoretical model to simulate various temperature profiles of the freeze-drying process. Good agreement between the experimental and the simulated results was found.


2008 ◽  
Vol 26 (4) ◽  
pp. 508-512 ◽  
Author(s):  
Arun Muthukumaran ◽  
Cristina Ratti ◽  
Vijaya G. S. Raghavan

2020 ◽  
pp. 33-42
Author(s):  
Konstantin Alekseyev ◽  
Evgeniya Blynskaya ◽  
Sergey Tishkov

During lyophilization frozen water and moisture associated with dissolved substances are removed, desorption occurs in the process of secondary drying. This stage is one of the main stages of the technological process in terms of duration comparable with primary freeze drying and is of paramount importance for the further storage of lyophilisates. Mathematical modeling of secondary drying and the use of these methods in calculating design space of the process are described in the presented article. The equations for calculating the rate of secondary drying, residual moisture, and other conditions on the basis of values of the temperature of the heat-transfer fluid and pressure in the freezedrying chamber are shown. Possibilities for determining design space boundaries on the basis of the composition of lyophilisate, required values of residual moisture and drying kinetics are demonstrated. The proposed mathematical model makes it possible to estimate the duration of the secondary drying process for various values of temperature and pressure in the chamber within the design space.


Cryobiology ◽  
1981 ◽  
Vol 18 (2) ◽  
pp. 155-165 ◽  
Author(s):  
Tsvetan D. Tsvetkov ◽  
Nikolai L. Vulchanov

2008 ◽  
Vol 26 (4) ◽  
pp. 513-518 ◽  
Author(s):  
Arun Muthukumaran ◽  
Cristina Ratti ◽  
Vijaya G. S. Raghavan

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