期刊名称：Revista de Investigación, Desarrollo e Innovación
印刷版ISSN：2027-8306
电子版ISSN：2389-9417
出版年度：2020
卷号：11
期号：1
页码：159-172
DOI：10.19053/20278306.v11.n1.2020.11690
出版社：Universidad Pedagógica y Tecnológica de Colombia
其他摘要：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.
