Cargando…

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...

Descripción completa

Detalles Bibliográficos
Autores principales: Srinivasan, Jayasree M., Sacha, Gregory A., Kshirsagar, Vaibhav, Alexeenko, Alina, Nail, Steven L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
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
_version_ 1783638264538726400
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
work_keys_str_mv AT srinivasanjayasreem equipmentcapabilitymeasurementoflaboratoryfreezedryersacomparisonoftwomethods
AT sachagregorya equipmentcapabilitymeasurementoflaboratoryfreezedryersacomparisonoftwomethods
AT kshirsagarvaibhav equipmentcapabilitymeasurementoflaboratoryfreezedryersacomparisonoftwomethods
AT alexeenkoalina equipmentcapabilitymeasurementoflaboratoryfreezedryersacomparisonoftwomethods
AT nailstevenl equipmentcapabilitymeasurementoflaboratoryfreezedryersacomparisonoftwomethods