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

Abstract

A rigorous unsteady state and spatially multidimensional model is presented and solved to describe the dynamic behavior of the primary and secondary drying stages of the lyophilization of a pharmaceutical product in vials for different operational policies. the results in this work strongly motivate the aggressive control of freeze drying and it is found that heat input control that runs the process close to the melting and scorch temperature constraints yields (i) faster drying times, and (ii) more uniform distributions of temperature and concentration of bound water at the end of the secondary drying stage. a rigorous unsteady state and spatially multidimensional model is presented and solved to describe the dynamic behavior of the primary and secondary drying stages of the lyophilization of a pharmaceutical product in vials for different operational policies. the results in this work strongly motivate the aggressive control of freeze drying and it is found that heat input control that runs the process close to the melting and scorch temperature constraints yields (i) faster drying times, and (ii) more uniform distributions of temperature and concentration of bound water at the end of the secondary drying stage.

Department(s)

Chemical and Biochemical Engineering

Sponsor(s)

University of Missouri--Rolla. Biochemical Processing Institute
Jefferson Smurfit Fellowship

Keywords and Phrases

Distribution of Bound Water; Freeze Drying in Vials; Lyophilization in Vials; Surface Geometry of Moving Interface; Velocity of Moving Interface

International Standard Serial Number (ISSN)

0006-3592

Document Type

Article - Journal

Document Version

Citation

File Type

text

Language(s)

English

Rights

© 1998 Wiley-Blackwell, All rights reserved.

Publication Date

01 Dec 1998

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