Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine

The chosen container-closure systems must be compatible with the preparation for which they are applied throughout their validity period. In the present work, the evaluation of the nitrile rubber stopper (RL8-9-105 / 0) was carried out in substitution of the acrylonitrile rubber stopper (FM84 / 5) a...

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Autores:
Tipo de recurso:
http://purl.org/coar/resource_type/c_6707
Fecha de publicación:
2020
Institución:
Universidad Pedagógica y Tecnológica de Colombia
Repositorio:
RiUPTC: Repositorio Institucional UPTC
Idioma:
spa
OAI Identifier:
oai:repositorio.uptc.edu.co:001/10342
Acceso en línea:
https://revistas.uptc.edu.co/index.php/investigacion_duitama/article/view/11690
https://repositorio.uptc.edu.co/handle/001/10342
Palabra clave:
quality;
sterility;
impermeability;
Gavac®vaccine
calidad;
esterilidad;
hermeticidad;
inmunógeno Gavac®
Rights
License
Derechos de autor 2020 REVISTA DE INVESTIGACIÓN, DESARROLLO E INNOVACIÓN
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network_name_str RiUPTC: Repositorio Institucional UPTC
repository_id_str
spelling 2020-08-152024-07-05T18:04:08Z2024-07-05T18:04:08Zhttps://revistas.uptc.edu.co/index.php/investigacion_duitama/article/view/1169010.19053/20278306.v11.n1.2020.11690https://repositorio.uptc.edu.co/handle/001/10342The chosen container-closure systems must be compatible with the preparation for which they are applied throughout their validity period. In the present work, the evaluation of the nitrile rubber stopper (RL8-9-105 / 0) was carried out in substitution of the acrylonitrile rubber stopper (FM84 / 5) as a container-closure system for the Gavac® immunogen. The statistical software Statgraphics® Plus 5.1 was used for data processing. A risk management analysis was carried out by means of a cause and effect diagram, the conformity of this cap with the quality specifications referred to in NP 1078 was determined, the physicochemical characteristics of both caps were compared according to the characteristics manufacturer's quality standard, the effect of placebo on the physical properties of the stopper was determined and the container-closure system using the nitrile rubber stopper was evaluated by means of a tightness test and a sterility test. It was concluded that the RL8-9-105 / 0 nitrile rubber stopper can be used as a container-closure system for the Gavac® immunogen, without affecting its main quality parameters.Los sistemas de envase-cierre escogidos, tienen que ser compatibles con el preparado para el cual se aplican a lo largo de su período de validez. En el presente trabajo se realizó la evaluación del tapón de caucho nitrilo (RL8-9-105/0) en sustitución del tapón de caucho acrilonitrilo (FM84/5) como sistema de envase-cierre del inmunógeno Gavac®. Se empleó el software estadístico Statgraphics® Plus 5.1, para el procesamiento de los datos. Se llevó a cabo un análisis de la gestión de riesgo mediante un diagrama de causa y efecto, se determinó la conformidad de este tapón con las especificaciones de calidad referidas en el NP 1078, se compararon las características físico-químicas de ambos tapones según las características de calidad del fabricante, se determinó el efecto del placebo sobre las propiedades físicas del tapón y se evaluó el sistema envase-cierre utilizando el tapón de caucho nitrilo mediante un ensayo de hermeticidad y una prueba de esterilidad. Se concluyó que el tapón de caucho nitrilo RL8-9-105/0 puede ser empleado como sistema de envase-cierre del inmunógeno Gavac®, sin que se afecten sus principales parámetros de calidad.application/pdftext/xmlspaspaUniversidad Pedagógica y Tecnológica de Colombiahttps://revistas.uptc.edu.co/index.php/investigacion_duitama/article/view/11690/9753https://revistas.uptc.edu.co/index.php/investigacion_duitama/article/view/11690/11248Derechos de autor 2020 REVISTA DE INVESTIGACIÓN, DESARROLLO E INNOVACIÓNhttp://purl.org/coar/access_right/c_abf208http://purl.org/coar/access_right/c_abf2Revista de Investigación, Desarrollo e Innovación; Vol. 11 No. 1 (2020): Julio-Diciembre; 159-172Revista de Investigación, Desarrollo e Innovación; Vol. 11 Núm. 1 (2020): Julio-Diciembre; 159-1722389-94172027-8306quality;sterility;impermeability;Gavac®vaccinecalidad;esterilidad;hermeticidad;inmunógeno Gavac®Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccineEvaluación de un tapón de caucho nitrilo como sistema de envase-cierre del inmunógeno Gavac®info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6707http://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/publishedVersionhttp://purl.org/coar/version/c_970fb48d4fbd8a291http://purl.org/coar/version/c_970fb48d4fbd8a85Pérez-Sánchez, AmauryAlfaro-Martínez, ArlenisSegura-Silva, Rutdali MaríaZamora-Sánchez, JesúsPérez-González, EikelMartínez-Armas, LidianaSalinas-Rodríguez, DiasmarysMoreira-Rubio, Alain001/10342oai:repositorio.uptc.edu.co:001/103422025-07-18 11:51:36.51metadata.onlyhttps://repositorio.uptc.edu.coRepositorio Institucional UPTCrepositorio.uptc@uptc.edu.co
dc.title.en-US.fl_str_mv Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine
dc.title.es-ES.fl_str_mv Evaluación de un tapón de caucho nitrilo como sistema de envase-cierre del inmunógeno Gavac®
title Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine
spellingShingle Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine
quality;
sterility;
impermeability;
Gavac®vaccine
calidad;
esterilidad;
hermeticidad;
inmunógeno Gavac®
title_short Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine
title_full Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine
title_fullStr Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine
title_full_unstemmed Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine
title_sort Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine
dc.subject.en-US.fl_str_mv quality;
sterility;
impermeability;
Gavac®vaccine
topic quality;
sterility;
impermeability;
Gavac®vaccine
calidad;
esterilidad;
hermeticidad;
inmunógeno Gavac®
dc.subject.es-ES.fl_str_mv calidad;
esterilidad;
hermeticidad;
inmunógeno Gavac®
description The chosen container-closure systems must be compatible with the preparation for which they are applied throughout their validity period. In the present work, the evaluation of the nitrile rubber stopper (RL8-9-105 / 0) was carried out in substitution of the acrylonitrile rubber stopper (FM84 / 5) as a container-closure system for the Gavac® immunogen. The statistical software Statgraphics® Plus 5.1 was used for data processing. A risk management analysis was carried out by means of a cause and effect diagram, the conformity of this cap with the quality specifications referred to in NP 1078 was determined, the physicochemical characteristics of both caps were compared according to the characteristics manufacturer's quality standard, the effect of placebo on the physical properties of the stopper was determined and the container-closure system using the nitrile rubber stopper was evaluated by means of a tightness test and a sterility test. It was concluded that the RL8-9-105 / 0 nitrile rubber stopper can be used as a container-closure system for the Gavac® immunogen, without affecting its main quality parameters.
publishDate 2020
dc.date.accessioned.none.fl_str_mv 2024-07-05T18:04:08Z
dc.date.available.none.fl_str_mv 2024-07-05T18:04:08Z
dc.date.none.fl_str_mv 2020-08-15
dc.type.none.fl_str_mv info:eu-repo/semantics/article
dc.type.coar.fl_str_mv http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.coarversion.fl_str_mv http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.coar.spa.fl_str_mv http://purl.org/coar/resource_type/c_6707
dc.type.version.spa.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.coarversion.spa.fl_str_mv http://purl.org/coar/version/c_970fb48d4fbd8a291
format http://purl.org/coar/resource_type/c_6707
status_str publishedVersion
dc.identifier.none.fl_str_mv https://revistas.uptc.edu.co/index.php/investigacion_duitama/article/view/11690
10.19053/20278306.v11.n1.2020.11690
dc.identifier.uri.none.fl_str_mv https://repositorio.uptc.edu.co/handle/001/10342
url https://revistas.uptc.edu.co/index.php/investigacion_duitama/article/view/11690
https://repositorio.uptc.edu.co/handle/001/10342
identifier_str_mv 10.19053/20278306.v11.n1.2020.11690
dc.language.none.fl_str_mv spa
dc.language.iso.spa.fl_str_mv spa
language spa
dc.relation.none.fl_str_mv https://revistas.uptc.edu.co/index.php/investigacion_duitama/article/view/11690/9753
https://revistas.uptc.edu.co/index.php/investigacion_duitama/article/view/11690/11248
dc.rights.es-ES.fl_str_mv Derechos de autor 2020 REVISTA DE INVESTIGACIÓN, DESARROLLO E INNOVACIÓN
dc.rights.coar.fl_str_mv http://purl.org/coar/access_right/c_abf2
dc.rights.coar.spa.fl_str_mv http://purl.org/coar/access_right/c_abf208
rights_invalid_str_mv Derechos de autor 2020 REVISTA DE INVESTIGACIÓN, DESARROLLO E INNOVACIÓN
http://purl.org/coar/access_right/c_abf208
http://purl.org/coar/access_right/c_abf2
dc.format.none.fl_str_mv application/pdf
text/xml
dc.publisher.es-ES.fl_str_mv Universidad Pedagógica y Tecnológica de Colombia
dc.source.en-US.fl_str_mv Revista de Investigación, Desarrollo e Innovación; Vol. 11 No. 1 (2020): Julio-Diciembre; 159-172
dc.source.es-ES.fl_str_mv Revista de Investigación, Desarrollo e Innovación; Vol. 11 Núm. 1 (2020): Julio-Diciembre; 159-172
dc.source.none.fl_str_mv 2389-9417
2027-8306
institution Universidad Pedagógica y Tecnológica de Colombia
repository.name.fl_str_mv Repositorio Institucional UPTC
repository.mail.fl_str_mv repositorio.uptc@uptc.edu.co
_version_ 1839633858582020096

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