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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| Format: | Online |
| Language: | spa |
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Universidad Pedagógica y Tecnológica de Colombia
2020
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| Online Access: | https://revistas.uptc.edu.co/index.php/investigacion_duitama/article/view/11690 |
| _version_ | 1801706001735352320 |
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| author | Pérez-Sánchez, Amaury Alfaro-Martínez, Arlenis Segura-Silva, Rutdali María Zamora-Sánchez, Jesús Pérez-González, Eikel Martínez-Armas, Lidiana Salinas-Rodríguez, Diasmarys Moreira-Rubio, Alain |
| author_facet | Pérez-Sánchez, Amaury Alfaro-Martínez, Arlenis Segura-Silva, Rutdali María Zamora-Sánchez, Jesús Pérez-González, Eikel Martínez-Armas, Lidiana Salinas-Rodríguez, Diasmarys Moreira-Rubio, Alain |
| author_sort | Pérez-Sánchez, Amaury |
| collection | OJS |
| 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. |
| format | Online |
| id | oai:oai.revistas.uptc.edu.co:article-11690 |
| institution | Revista de Investigación, Desarrollo e Innovación (RIDI) |
| language | spa |
| publishDate | 2020 |
| publisher | Universidad Pedagógica y Tecnológica de Colombia |
| record_format | ojs |
| spelling | oai:oai.revistas.uptc.edu.co:article-116902021-12-10T01:30:59Z Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine Evaluación de un tapón de caucho nitrilo como sistema de envase-cierre del inmunógeno Gavac® Pérez-Sánchez, Amaury Alfaro-Martínez, Arlenis Segura-Silva, Rutdali María Zamora-Sánchez, Jesús Pérez-González, Eikel Martínez-Armas, Lidiana Salinas-Rodríguez, Diasmarys Moreira-Rubio, Alain quality; sterility; impermeability; Gavac®vaccine calidad; esterilidad; hermeticidad; inmunógeno Gavac® 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. 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. Universidad Pedagógica y Tecnológica de Colombia 2020-08-15 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion application/pdf text/xml https://revistas.uptc.edu.co/index.php/investigacion_duitama/article/view/11690 10.19053/20278306.v11.n1.2020.11690 Revista de Investigación, Desarrollo e Innovación; Vol. 11 No. 1 (2020): Julio-Diciembre; 159-172 Revista de Investigación, Desarrollo e Innovación; Vol. 11 Núm. 1 (2020): Julio-Diciembre; 159-172 2389-9417 2027-8306 spa 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 Derechos de autor 2020 REVISTA DE INVESTIGACIÓN, DESARROLLO E INNOVACIÓN |
| spellingShingle | quality; sterility; impermeability; Gavac®vaccine calidad; esterilidad; hermeticidad; inmunógeno Gavac® Pérez-Sánchez, Amaury Alfaro-Martínez, Arlenis Segura-Silva, Rutdali María Zamora-Sánchez, Jesús Pérez-González, Eikel Martínez-Armas, Lidiana Salinas-Rodríguez, Diasmarys Moreira-Rubio, Alain Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine |
| title | Evaluation of a rubber nitrile stopper as container-closure system of Gavac® vaccine |
| title_alt | Evaluación de un tapón de caucho nitrilo como sistema de envase-cierre del inmunógeno Gavac® |
| 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_short | 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 r vaccine |
| topic | quality; sterility; impermeability; Gavac®vaccine calidad; esterilidad; hermeticidad; inmunógeno Gavac® |
| topic_facet | quality; sterility; impermeability; Gavac®vaccine calidad; esterilidad; hermeticidad; inmunógeno Gavac® |
| url | https://revistas.uptc.edu.co/index.php/investigacion_duitama/article/view/11690 |
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