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Use of a multi-vial mathematical model to design freeze-drying cycles for pharmaceuticals at known risk of failure

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Use of a multi-vial mathematical model to design freeze-drying cycles for pharmaceuticals at known risk of failure

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dc.contributor.author Scutellà, Bernadette es_ES
dc.contributor.author Trelea, Ioan Cristian es_ES
dc.contributor.author Bourlés, Erwan es_ES
dc.contributor.author Fonseca, Fernanda es_ES
dc.contributor.author Passot, Stephanie es_ES
dc.date.accessioned 2019-03-26T07:30:56Z
dc.date.available 2019-03-26T07:30:56Z
dc.date.issued 2018-09-07
dc.identifier.isbn 9788490486887
dc.identifier.uri http://hdl.handle.net/10251/118580
dc.description.abstract [EN] Freeze-drying is a dehydration method suitable for the stabilization of heat-labile pharmaceutical products, such as vaccines. Due to the vial-to-vial variability of heat and mass transfer during the process, the value of the critical process parameters (e.g., product temperature, sublimation rate) may be different between vials and batches often present significant product quality heterogeneity. The aim of this work was the development of a dynamic, multi-vial mathematical model making it possible to predict risk of failure of the process, defined as the percentage of vials potentially rejected by quality inspection. This tool could assist the design of freeze-drying cycle. es_ES
dc.description.sponsorship This work was sponsored by GlaxoSmithKline Biologicals SA which was involved in all stages of the study conduct and analysis es_ES
dc.format.extent 8 es_ES
dc.language Inglés es_ES
dc.publisher Editorial Universitat Politècnica de València es_ES
dc.relation.ispartof IDS 2018. 21st International Drying Symposium Proceedings es_ES
dc.rights Reserva de todos los derechos es_ES
dc.subject Drying es_ES
dc.subject Dehydration es_ES
dc.subject Dewatering es_ES
dc.subject Emerging technologies es_ES
dc.subject Products quality es_ES
dc.subject Process control es_ES
dc.subject Environmental es_ES
dc.subject Evaporation es_ES
dc.subject Sublimation es_ES
dc.subject Diffusion es_ES
dc.subject Energy es_ES
dc.subject Intensification es_ES
dc.subject Lyophilization es_ES
dc.subject Vaccines es_ES
dc.subject Heat and mass transfer es_ES
dc.subject Mathematical modeling es_ES
dc.subject Design space es_ES
dc.title Use of a multi-vial mathematical model to design freeze-drying cycles for pharmaceuticals at known risk of failure es_ES
dc.type Capítulo de libro es_ES
dc.type Comunicación en congreso es_ES
dc.identifier.doi 10.4995/IDS2018.2018.7421
dc.rights.accessRights Abierto es_ES
dc.description.bibliographicCitation Scutellà, B.; Trelea, IC.; Bourlés, E.; Fonseca, F.; Passot, S. (2018). Use of a multi-vial mathematical model to design freeze-drying cycles for pharmaceuticals at known risk of failure. En IDS 2018. 21st International Drying Symposium Proceedings. Editorial Universitat Politècnica de València. 315-322. https://doi.org/10.4995/IDS2018.2018.7421 es_ES
dc.description.accrualMethod OCS es_ES
dc.relation.conferencename 21st International Drying Symposium es_ES
dc.relation.conferencedate Septiembre 11-14, 2018 es_ES
dc.relation.conferenceplace Valencia, Spain es_ES
dc.relation.publisherversion http://ocs.editorial.upv.es/index.php/IDS/ids2018/paper/view/7421 es_ES
dc.description.upvformatpinicio 315 es_ES
dc.description.upvformatpfin 322 es_ES
dc.type.version info:eu-repo/semantics/publishedVersion es_ES
dc.relation.pasarela OCS\7421 es_ES
dc.contributor.funder GlaxoSmithKline


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