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Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods
The objective of this investigation was to evaluate two methods for measuring the maximum sublimation rate that a freeze-dryer will support—the minimum controllable pressure method and the choke point method. Both methods gave equivalent results, but the minimum controllable pressure method is prefe...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7815603/ https://www.ncbi.nlm.nih.gov/pubmed/33469853 http://dx.doi.org/10.1208/s12249-021-01921-2 |
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author | Srinivasan, Jayasree M. Sacha, Gregory A. Kshirsagar, Vaibhav Alexeenko, Alina Nail, Steven L. |
author_facet | Srinivasan, Jayasree M. Sacha, Gregory A. Kshirsagar, Vaibhav Alexeenko, Alina Nail, Steven L. |
author_sort | Srinivasan, Jayasree M. |
collection | PubMed |
description | The objective of this investigation was to evaluate two methods for measuring the maximum sublimation rate that a freeze-dryer will support—the minimum controllable pressure method and the choke point method. Both methods gave equivalent results, but the minimum controllable pressure method is preferred, since it is easier, faster, and less subjective. The ratio of chamber pressure to condenser pressure corresponding to the onset of choked flow was considerably higher in this investigation (up to about 20:1) than in previously published reports. This ratio was not affected by the location of the pressure gauge on the condenser; that is, on the foreline of the vacuum pump versus on the body of the condenser itself. The total water loss due to sublimation as measured by tunable diode laser absorption spectroscopy was consistently within 5% of gravimetrically determined weight loss, regardless of whether the measurement took place during choked versus non-choked process conditions. |
format | Online Article Text |
id | pubmed-7815603 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-78156032021-01-25 Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods Srinivasan, Jayasree M. Sacha, Gregory A. Kshirsagar, Vaibhav Alexeenko, Alina Nail, Steven L. AAPS PharmSciTech Research Article The objective of this investigation was to evaluate two methods for measuring the maximum sublimation rate that a freeze-dryer will support—the minimum controllable pressure method and the choke point method. Both methods gave equivalent results, but the minimum controllable pressure method is preferred, since it is easier, faster, and less subjective. The ratio of chamber pressure to condenser pressure corresponding to the onset of choked flow was considerably higher in this investigation (up to about 20:1) than in previously published reports. This ratio was not affected by the location of the pressure gauge on the condenser; that is, on the foreline of the vacuum pump versus on the body of the condenser itself. The total water loss due to sublimation as measured by tunable diode laser absorption spectroscopy was consistently within 5% of gravimetrically determined weight loss, regardless of whether the measurement took place during choked versus non-choked process conditions. Springer International Publishing 2021-01-19 /pmc/articles/PMC7815603/ /pubmed/33469853 http://dx.doi.org/10.1208/s12249-021-01921-2 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 Srinivasan, Jayasree M. Sacha, Gregory A. Kshirsagar, Vaibhav Alexeenko, Alina Nail, Steven L. Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods |
title | Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods |
title_full | Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods |
title_fullStr | Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods |
title_full_unstemmed | Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods |
title_short | Equipment Capability Measurement of Laboratory Freeze-Dryers: a Comparison of Two Methods |
title_sort | equipment capability measurement of laboratory freeze-dryers: a comparison of two methods |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7815603/ https://www.ncbi.nlm.nih.gov/pubmed/33469853 http://dx.doi.org/10.1208/s12249-021-01921-2 |
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