Applying quality-by-design to develop a coffee freeze-drying process

Abstract This paper aims at investigating the design of a freeze-drying cycle taking into account the energy utilization efficiency. A coffee freeze-drying process is considered as case study. The analysis is focused on the primary drying, as this stage accounts for most of the energy consumption. A simplified mathematical model is used to calculate the design space of the process, with the goal to point out the operating conditions (temperature of the heating shelf and pressure in the drying chamber) that allow satisfying the constraints of the process. Experimental investigation is required to determine model parameters, namely the coefficient of heat transfer to the product, and the resistance of the dried cake to vapor flow. The same model, coupled with equations describing the dynamics of the freeze-dryer, is used to carry out the exergy analysis of the process, thus pointing out the operating conditions that allow minimizing the exergy losses and maximizing the exergy efficiency.

[1]  Thomas A. Jennings,et al.  Lyophilization: Introduction and Basic Principles , 1999 .

[2]  Felix Franks,et al.  Freeze-drying of Pharmaceuticals and Biopharmaceuticals , 2007 .

[3]  Stanley E. Charm,et al.  Freeze Drying , 1964 .

[4]  Davide Fissore,et al.  On the Methods Based on the Pressure Rise Test for Monitoring a Freeze-Drying Process , 2010 .

[5]  R. Bruttini,et al.  Exergy analysis of freeze-drying of pharmaceuticals in vials on trays. , 2008 .

[6]  Davide Fissore,et al.  Advanced approach to build the design space for the primary drying of a pharmaceutical freeze-drying process. , 2011, Journal of pharmaceutical sciences.

[7]  Konrad Mauersberger,et al.  A survey and new measurements of ice vapor pressure at temperatures between 170 and 250K , 1993 .

[8]  Wolfgang Wagner,et al.  International Equations for the Pressure Along the Melting and Along the Sublimation Curve of Ordinary Water Substance , 1994 .

[9]  Davide Fissore,et al.  A Model-Based Framework to Optimize Pharmaceuticals Freeze Drying , 2012 .

[10]  Davide Fissore,et al.  In-line optimization and control of an industrial freeze-drying process for pharmaceuticals. , 2010, Journal of pharmaceutical sciences.

[11]  Swetaprovo Chaudhuri,et al.  Choked flow and importance of Mach I in freeze-drying process design , 2010 .

[12]  Davide Fissore,et al.  Freeze-drying cycle optimization using model predictive control techniques , 2011 .

[13]  Davide Fissore,et al.  Heat Transfer in Freeze-Drying Apparatus , 2011 .

[14]  D. D. McGehee.  OBSERVATION AND IMPLICATIONS OF LONG WAVES IN ST. JOSEPH BAY, FLORIDA , 2006 .

[15]  Antonello Barresi,et al.  Development of simplified models for the freeze-drying process and investigation of the optimal operating conditions , 2008 .

[16]  Davide Fissore,et al.  On the use of mathematical models to build the design space for the primary drying phase of a pharmaceutical lyophilization process. , 2011, Journal of pharmaceutical sciences.

[17]  King C.P. Li.  Imaging for drug development in the postgenomic era: Challenges and opportunities , 2004 .

[18]  Davide Fissore,et al.  In‐Line Product Quality Control of Pharmaceuticals in Freeze‐Drying Processes , 2011 .

[19]  M. Pikal,et al.  Mass and heat transfer in vial freeze-drying of pharmaceuticals: role of the vial. , 1984, Journal of pharmaceutical sciences.

[20]  Michael J. Pikal,et al.  Determination of End Point of Primary Drying in Freeze-Drying Process Control , 2010, AAPS PharmSciTech.

[21]  Xiao Feng,et al.  Exergy analysis for a freeze-drying process , 2008 .

[22]  Cristina Ratti,et al.  Hot air and freeze-drying of high-value foods : a review , 2001 .

[23]  P Sheehan,et al.  Modeling of the primary and secondary drying stages of the freeze drying of pharmaceutical products in vials: numerical results obtained from the solution of a dynamic and spatially multi-dimensional lyophilization model for different operational policies. , 1998, Biotechnology and bioengineering.

[24]  M. Pikal,et al.  Use of laboratory data in freeze drying process design: heat and mass transfer coefficients and the computer simulation of freeze drying. , 1985, Journal of parenteral science and technology : a publication of the Parenteral Drug Association.

[25]  Davide Fissore,et al.  Quality by design: optimization of a freeze-drying cycle via design space in case of heterogeneous drying behavior and influence of the freezing protocol , 2013, Pharmaceutical development and technology.

[26]  J. Mellor,et al.  Fundamentals of Freeze-Drying , 1978 .

[27]  Steven L. Nail,et al.  Elements of Quality by Design in Development and Scale-Up of Freeze-Dried Parenterals , 2008 .