Freeze-Dryer Equipment Capability Limit: Comparison of Computational Modeling With Experiments at Laboratory Scale
| Autor: | Steven L. Nail, Tong Zhu, Gregory A. Sacha, Gayathri Shivkumar, Vaibhav Kshirsagar, Israel B. Sebastião, Alina Alexeenko |
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| Rok vydání: | 2019 |
| Předmět: |
Computer science
Temperature Nucleation Pharmaceutical Science Mechanical engineering Isolation valve Process design Choke 02 engineering and technology Models Theoretical Laboratory scale 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy 03 medical and health sciences Freeze Drying 0302 clinical medicine Bounding overwatch Pressure Computer-Aided Design Technology Pharmaceutical Computer Simulation Duct (flow) Sublimation (phase transition) 0210 nano-technology |
| Zdroj: | Journal of Pharmaceutical Sciences. 108:2972-2981 |
| ISSN: | 0022-3549 |
| DOI: | 10.1016/j.xphs.2019.04.016 |
| Popis: | The equipment capability curve is one of the bounding elements of the freeze-drying design space, and understanding it is critical to process design, transfer, and scale-up. The second bounding element of the design space is the product temperature limit beyond which the product collapses. The high cost associated with freeze-drying any product renders it crucial to operate using the most efficient cycle within the limits of the equipment and the product. In this work, we present a computational model to generate the equipment capability curve for 2 laboratory scale freeze-dryers and compare the results to experimentally generated equipment capability curves. The average deviations of the modeling results from the experiments for the 2 lyophilizers modeled are −4.8% and −7.2%. In addition, we investigate the effect of various numerical and geometric parameters on the simulated equipment capability. Among the numerical parameters, the chamber wall thermal boundary conditions exert the largest influence with a maximum value of 12.3%. Among the geometric parameters, the inclusion of the isolation valve reduces the equipment capability by 23.7%. Larger isolation valves, required for controlled nucleation technology, choke the flow in the duct at lower sublimation rates, thereby lowering the equipment capability limit. |
| Databáze: | OpenAIRE |
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