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Molded Vial Manufacturing and Its Impact on Heat Transfer during Freeze-Drying: Vial Geometry Considerations

Recent advances in molded vial manufacturing enabled manufacturers to use a new manufacturing technique to achieve superior homogeneity of the vial wall thickness. This study evaluated the influence of the different manufacturing techniques of molded vials and glass compositions on vial heat transfe...

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Autores principales: Wenzel, Tim, Gieseler, Henning
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7840647/
https://www.ncbi.nlm.nih.gov/pubmed/33502633
http://dx.doi.org/10.1208/s12249-021-01926-x
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author Wenzel, Tim
Gieseler, Henning
author_facet Wenzel, Tim
Gieseler, Henning
author_sort Wenzel, Tim
collection PubMed
description Recent advances in molded vial manufacturing enabled manufacturers to use a new manufacturing technique to achieve superior homogeneity of the vial wall thickness. This study evaluated the influence of the different manufacturing techniques of molded vials and glass compositions on vial heat transfer in freeze-drying. Additionally, the influence of using empty vials as thermal shielding on thermal characteristics of edge and center vials was investigated. The vial heat transfer coefficient K(v) was determined gravimetrically for multiple vial systems. The results showed superior heat transfer characteristics of the novel manufacturing technique as well as differences in heat transfer for the different glass compositions. Empty vials on the outside of the array did not influence center vial K(v) values compared to a full array. The direct contact area and vial bottom curvature and their correlation to heat transfer parameters were analyzed across multiple vial systems. A new approach based on light microscopy to describe the vial bottom curvature more accurately was described. The presented results for the contact area allowed for an approximation of the pressure-independent heat transfer parameter KC. The results for the vial bottom curvature showed a great correlation to the pressure-dependent heat transfer parameter KD. Overall, the results highlighted how a thorough geometrical characterization of vials with known heat transfer characteristics could be used to predict thermal characteristics of new vial systems as an alternative to a time-consuming gravimetric K(v) determination. Primary drying times were simulated to show the influence of K(v) on drying performance.
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spelling pubmed-78406472021-02-04 Molded Vial Manufacturing and Its Impact on Heat Transfer during Freeze-Drying: Vial Geometry Considerations Wenzel, Tim Gieseler, Henning AAPS PharmSciTech Research Article Recent advances in molded vial manufacturing enabled manufacturers to use a new manufacturing technique to achieve superior homogeneity of the vial wall thickness. This study evaluated the influence of the different manufacturing techniques of molded vials and glass compositions on vial heat transfer in freeze-drying. Additionally, the influence of using empty vials as thermal shielding on thermal characteristics of edge and center vials was investigated. The vial heat transfer coefficient K(v) was determined gravimetrically for multiple vial systems. The results showed superior heat transfer characteristics of the novel manufacturing technique as well as differences in heat transfer for the different glass compositions. Empty vials on the outside of the array did not influence center vial K(v) values compared to a full array. The direct contact area and vial bottom curvature and their correlation to heat transfer parameters were analyzed across multiple vial systems. A new approach based on light microscopy to describe the vial bottom curvature more accurately was described. The presented results for the contact area allowed for an approximation of the pressure-independent heat transfer parameter KC. The results for the vial bottom curvature showed a great correlation to the pressure-dependent heat transfer parameter KD. Overall, the results highlighted how a thorough geometrical characterization of vials with known heat transfer characteristics could be used to predict thermal characteristics of new vial systems as an alternative to a time-consuming gravimetric K(v) determination. Primary drying times were simulated to show the influence of K(v) on drying performance. Springer International Publishing 2021-01-27 /pmc/articles/PMC7840647/ /pubmed/33502633 http://dx.doi.org/10.1208/s12249-021-01926-x Text en © The Author(s) 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Research Article
Wenzel, Tim
Gieseler, Henning
Molded Vial Manufacturing and Its Impact on Heat Transfer during Freeze-Drying: Vial Geometry Considerations
title Molded Vial Manufacturing and Its Impact on Heat Transfer during Freeze-Drying: Vial Geometry Considerations
title_full Molded Vial Manufacturing and Its Impact on Heat Transfer during Freeze-Drying: Vial Geometry Considerations
title_fullStr Molded Vial Manufacturing and Its Impact on Heat Transfer during Freeze-Drying: Vial Geometry Considerations
title_full_unstemmed Molded Vial Manufacturing and Its Impact on Heat Transfer during Freeze-Drying: Vial Geometry Considerations
title_short Molded Vial Manufacturing and Its Impact on Heat Transfer during Freeze-Drying: Vial Geometry Considerations
title_sort molded vial manufacturing and its impact on heat transfer during freeze-drying: vial geometry considerations
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7840647/
https://www.ncbi.nlm.nih.gov/pubmed/33502633
http://dx.doi.org/10.1208/s12249-021-01926-x
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