Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company
Autor(a) principal: | |
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Data de Publicação: | 2016 |
Tipo de documento: | Dissertação |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10451/28420 |
Resumo: | Tese de mestrado, Engenharia Farmacêutica, Universidade de Lisboa, Faculdade de Farmácia, 2016 |
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Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical companyProcess Analytical TechnologyNear InfraredQuality-by-designEconomic analysisReal time releaseTeses de mestrado - 2016Ciências da SaúdeTese de mestrado, Engenharia Farmacêutica, Universidade de Lisboa, Faculdade de Farmácia, 2016Process Analytical Technology (PAT) is defined by the FDA in the PAT initiative issued in 2004 as ”a system for designing, analyzing, and controlling manufacturing through timelymeasurements (i.e.,during processing) of critical quality and performance attributes of raw and inprocess materials and processes, with the goal of ensuring the final product quality”. Since then, the pharmaceutical companies have been adopting gradually this technology in their manufacturing lines. PAT tools are indeed well recognized as a critical tool for achieving better process and product control leading to the possibility of real time release testing. This thesis evaluated the technical and economic feasibility of implementation of PAT systems into a Portuguese pharmaceutical company manufacturing line of solid forms. To accomplish this task, two products were used as models. These products were selected since they cover most unit operations of the solid forms installed manufacturing line. The work was divided in two parts. The first part is concerned with the identification of critical quality attributes (CQAs) and critical process parameters (CPPs) of the two model products in order for the proposition of opportunities of implementation of PAT strategies. These opportunities are described in detail and evaluated according to a series of criteria. Nine opportunities were identified, mainly involving NIR and RAMAN spectroscopy as suitable technology. The implementation of the identified opportunities, is expected to permit the possibility of real time release for the two products. The second part focuses on the economical feasibility of the identified PAT implementation. The economic analysis indicated that the implementation of all opportunities will reduce manufacturing / quality control time and costs substantially. The expectation of return-of-investmentis achieved in a time frame between 5 to 8 years respectively considering optimistic and pessimist scenarios.Lopes, João AlmeidaBica, AntónioRepositório da Universidade de LisboaCordeiro, Pedro Miguel António2017-07-19T15:18:24Z2016-07-212016-05-312016-07-21T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/masterThesisapplication/pdfhttp://hdl.handle.net/10451/28420TID:201487136enginfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-08T16:20:17Zoai:repositorio.ul.pt:10451/28420Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T21:44:42.924259Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company |
title |
Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company |
spellingShingle |
Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company Cordeiro, Pedro Miguel António Process Analytical Technology Near Infrared Quality-by-design Economic analysis Real time release Teses de mestrado - 2016 Ciências da Saúde |
title_short |
Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company |
title_full |
Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company |
title_fullStr |
Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company |
title_full_unstemmed |
Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company |
title_sort |
Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company |
author |
Cordeiro, Pedro Miguel António |
author_facet |
Cordeiro, Pedro Miguel António |
author_role |
author |
dc.contributor.none.fl_str_mv |
Lopes, João Almeida Bica, António Repositório da Universidade de Lisboa |
dc.contributor.author.fl_str_mv |
Cordeiro, Pedro Miguel António |
dc.subject.por.fl_str_mv |
Process Analytical Technology Near Infrared Quality-by-design Economic analysis Real time release Teses de mestrado - 2016 Ciências da Saúde |
topic |
Process Analytical Technology Near Infrared Quality-by-design Economic analysis Real time release Teses de mestrado - 2016 Ciências da Saúde |
description |
Tese de mestrado, Engenharia Farmacêutica, Universidade de Lisboa, Faculdade de Farmácia, 2016 |
publishDate |
2016 |
dc.date.none.fl_str_mv |
2016-07-21 2016-05-31 2016-07-21T00:00:00Z 2017-07-19T15:18:24Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/masterThesis |
format |
masterThesis |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10451/28420 TID:201487136 |
url |
http://hdl.handle.net/10451/28420 |
identifier_str_mv |
TID:201487136 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.source.none.fl_str_mv |
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instname_str |
Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
instacron_str |
RCAAP |
institution |
RCAAP |
reponame_str |
Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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1799134368128565248 |