A proposal of process validation in the implementation of Good Manufacturing Practices in brachytherapy sources production

Página do item simplificado
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.coverageNacionalpt_BR
dc.date.accessioned2021-08-02T17:09:53Z
dc.date.available2021-08-02T17:09:53Z
dc.date.issued2021pt_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 the quality system. The process validation results in a document that certifies that any procedure, process, equipment, material, operation, or system 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 does not have an established parameter, since is visually evaluated by the operator, and the leakage detection must be 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.format.extent1-8pt_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. <b>Brazilian Journal of Radiation Sciences</b>, v. 9, n. 1A, p. 1-8, 2021. DOI: <a href="https://dx.doi.org/10.15392/bjrs.v9i1A.1285">10.15392/bjrs.v9i1A.1285</a>. Disponível em: http://repositorio.ipen.br/handle/123456789/32086.
dc.identifier.doi10.15392/bjrs.v9i1A.1285pt_BR
dc.identifier.fasciculo1Apt_BR
dc.identifier.issn2319-0612pt_BR
dc.identifier.orcid0000-0003-2943-6097pt_BR
dc.identifier.orcid0000-0002-7303-6720pt_BR
dc.identifier.orcidhttps://orcid.org/0000-0003-2943-6097
dc.identifier.orcidhttps://orcid.org/0000-0002-5054-0799
dc.identifier.orcidhttps://orcid.org/0000-0002-7303-6720
dc.identifier.percentilfiSem Percentilpt_BR
dc.identifier.urihttp://repositorio.ipen.br/handle/123456789/32086
dc.identifier.vol9pt_BR
dc.relation.ispartofBrazilian Journal of Radiation Sciencespt_BR
dc.rightsopenAccesspt_BR
dc.sourceMeeting on Nuclear Applications (ENAN), 14th, October 21-25, 2019, Santos, SPpt_BR
dc.subjectbrachytherapy
dc.subjectcertification
dc.subjectimplementation
dc.subjectiodine 125
dc.subjectmanufacturing
dc.subjectquality control
dc.subjectradiation sources
dc.subjectvalidation
dc.titleA proposal of process validation in the implementation of Good Manufacturing Practices in brachytherapy sources productionpt_BR
dc.typeArtigo de periódicopt_BR
dspace.entity.typePublication
ipen.autorBRUNA TEIGA RODRIGUES
ipen.autorMARIA ELISA CHUERY MARTINS ROSTELATO
ipen.autorJOÃO AUGUSTO MOURA
ipen.autorCARLOS ALBERTO ZEITUNI
ipen.autorANSELMO FEHER
ipen.autorTATYANA SPINOSA BAPTISTA
ipen.codigoautor11600
ipen.codigoautor7
ipen.codigoautor6611
ipen.codigoautor944
ipen.codigoautor786
ipen.codigoautor7230
ipen.contributor.ipenauthorBRUNA TEIGA RODRIGUES
ipen.contributor.ipenauthorMARIA ELISA CHUERY MARTINS ROSTELATO
ipen.contributor.ipenauthorJOÃO AUGUSTO MOURA
ipen.contributor.ipenauthorCARLOS ALBERTO ZEITUNI
ipen.contributor.ipenauthorANSELMO FEHER
ipen.contributor.ipenauthorTATYANA SPINOSA BAPTISTA
ipen.date.recebimento21-08
ipen.identifier.fiSem F.I.pt_BR
ipen.identifier.ipendoc27857pt_BR
ipen.type.genreArtigo
relation.isAuthorOfPublication3b25db9e-d05b-4fe0-b2a1-ab6b0c67d5ab
relation.isAuthorOfPublicationda77b491-04ff-4c68-aa65-dead9208a48c
relation.isAuthorOfPublication6a96a2fe-6eb6-488b-bd21-ac2b4e1335a3
relation.isAuthorOfPublication02421b96-adef-4759-b25e-67d4759aa676
relation.isAuthorOfPublication52268eaa-9747-4444-b301-7e33219b912c
relation.isAuthorOfPublication1a426adc-cb37-4a28-92b5-69c9a294b998
relation.isAuthorOfPublication.latestForDiscovery1a426adc-cb37-4a28-92b5-69c9a294b998
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.:7230:230:Spt_BR
Pacote Original
Agora exibindo 1 - 1 de 1
Imagem de Miniatura
Nome:
27857.pdf
Tamanho:
449.19 KB
Formato:
Adobe Portable Document Format
Descrição:
Baixar
Licença do Pacote
Agora exibindo 1 - 1 de 1
Nenhuma Miniatura disponível
Nome:
license.txt
Tamanho:
1.71 KB
Formato:
Item-specific license agreed upon to submission
Descrição:
Baixar
Coleções
Periódicos