Evaluation of the cost-benefit of the implementation of PAT systems for the production of solid forms in a pharmaceutical company

Detalhes bibliográficos
Autor(a) principal: Cordeiro, Pedro Miguel António
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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spelling 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 reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
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)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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