A proposal of process validation in the implementation of good manufacturing practices in brachytherapy sources production

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dc.contributor.authorBAPTISTA, TATYANA S.pt_BR
dc.contributor.authorFEHER, ANSELMOpt_BR
dc.contributor.authorRODRIGUES, BRUNA T.pt_BR
dc.contributor.authorZEITUNI, CARLOS A.pt_BR
dc.contributor.authorMOURA, JOÃO A.pt_BR
dc.contributor.authorROSTELATO, MARIA E.C.M.pt_BR
dc.coverageInternacionalpt_BR
dc.creator.eventoINTERNATIONAL NUCLEAR ATLANTIC CONFERENCEpt_BR
dc.date.accessioned2020-01-07T11:12:13Z
dc.date.available2020-01-07T11:12:13Z
dc.date.eventoOctober 21-25, 2019pt_BR
dc.description.abstractNew laboratories for brachytherapy sources production are being implemented in our facility at IPEN, in São Paulo. A great challenge implementing a production laboratory is to comply with the Good Manufacturing Practices (GMPs), which involves process validation and all supporting activities such as cleaning and sanitization. Much more than compliance with regulatory guidelines, required for certification and inspections, a validation builds large process knowledge, provides possibilities for optimization and improvement, increasing the degree of maturity of all people involved and also the quality system as a whole. The process validation results in a document that certifies that any procedure, process, equipment, material, operation or system actually leads to the expected results. This work focused on the new laboratory, been assembled to produce small iodine-125 seeds. The process validation was performed three times for evaluation. The parameters evaluated in this study were: the source welding efficiency and the leakage tests results (immersion test). The welding efficiency doesn’t have an established parameter, since is visually evaluated by the operator, and the leakage detection has to e under 5 nCi / 185 Bq, accordingly with the ISO 9978. We observed values were: average 79-87% production efficiency and leakage tests were under 5 nCi/seed. Although established values for the global efficiency aren’t available in the literature, the results showed high consistency and acceptable percentages, especially when other similar manufacturing processes are used in comparison (average 85-70% found in the literature for other similar metallic structures). Those values will be important data when drafting the validation document and to follow the Good Manufacturing Practices (GMPs).pt_BR
dc.event.siglaINACpt_BR
dc.format.extent1730-1735pt_BR
dc.identifier.citationBAPTISTA, TATYANA S.; FEHER, ANSELMO; RODRIGUES, BRUNA T.; ZEITUNI, CARLOS A.; MOURA, JOÃO A.; ROSTELATO, MARIA E.C.M. A proposal of process validation in the implementation of good manufacturing practices in brachytherapy sources production. In: INTERNATIONAL NUCLEAR ATLANTIC CONFERENCE, October 21-25, 2019, Santos, SP. <b>Proceedings...</b> Rio de Janeiro: Associação Brasileira de Energia Nuclear, 2019. p. 1730-1735. Disponível em: http://repositorio.ipen.br/handle/123456789/30579.
dc.identifier.orcid0000-0003-2943-6097pt_BR
dc.identifier.orcid0000-0002-7303-6720pt_BR
dc.identifier.orcidhttps://orcid.org/0000-0002-5054-0799
dc.identifier.orcidhttps://orcid.org/0000-0003-2943-6097
dc.identifier.orcidhttps://orcid.org/0000-0002-7303-6720
dc.identifier.urihttp://repositorio.ipen.br/handle/123456789/30579
dc.localRio de Janeiropt_BR
dc.local.eventoSantos, SPpt_BR
dc.publisherAssociação Brasileira de Energia Nuclear
dc.rightsopenAccesspt_BR
dc.subjectbrachytherapy
dc.subjectbrazilian cnen
dc.subjectcertification
dc.subjectdata
dc.subjectimplementation
dc.subjectiodine 125
dc.subjectlaboratories
dc.subjectquality assurance
dc.subjectradiation sources
dc.subjectseeds
dc.subjectvalidation
dc.titleA proposal of process validation in the implementation of good manufacturing practices in brachytherapy sources productionpt_BR
dc.typeTexto completo de eventopt_BR
dspace.entity.typePublication
ipen.autorJOÃO AUGUSTO MOURA
ipen.autorMARIA ELISA CHUERY MARTINS ROSTELATO
ipen.autorCARLOS ALBERTO ZEITUNI
ipen.autorBRUNA TEIGA RODRIGUES
ipen.autorANSELMO FEHER
ipen.autorTATYANA SPINOSA BAPTISTA
ipen.codigoautor6611
ipen.codigoautor7
ipen.codigoautor944
ipen.codigoautor11600
ipen.codigoautor786
ipen.codigoautor7230
ipen.contributor.ipenauthorJOÃO AUGUSTO MOURA
ipen.contributor.ipenauthorMARIA ELISA CHUERY MARTINS ROSTELATO
ipen.contributor.ipenauthorCARLOS ALBERTO ZEITUNI
ipen.contributor.ipenauthorBRUNA TEIGA RODRIGUES
ipen.contributor.ipenauthorANSELMO FEHER
ipen.contributor.ipenauthorTATYANA SPINOSA BAPTISTA
ipen.date.recebimento20-01
ipen.event.datapadronizada2019pt_BR
ipen.identifier.ipendoc26229pt_BR
ipen.notas.internasProceedingspt_BR
ipen.type.genreArtigo
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relation.isAuthorOfPublication.latestForDiscovery52268eaa-9747-4444-b301-7e33219b912c
sigepi.autor.atividadeROSTELATO, MARIA E.C.M.:7:230:Npt_BR
sigepi.autor.atividadeMOURA, JOÃO A.:6611:230:Npt_BR
sigepi.autor.atividadeZEITUNI, CARLOS A.:944:230:Npt_BR
sigepi.autor.atividadeRODRIGUES, BRUNA T.:11600:230:Npt_BR
sigepi.autor.atividadeFEHER, ANSELMO:786:230:Npt_BR
sigepi.autor.atividadeBAPTISTA, TATYANA S.:7230:-1:Spt_BR
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