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Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test

The sterility test described in pharmacopoeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the BacT/Alert® 3D system, is particularly interesting, because it allows...

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Detalles Bibliográficos
Autores principales: Bugno, Adriana, Saes, Deborah Pita Sanches, Almodovar, Adriana Aparecida Buzzo, Dua, Kamal, Awasthi, Rajendra, Ghisleni, Daniela Dal Molim, Hirota, Marici Tiomi, de Oliveira, Wesley Anderson, de Jesus Andreoli Pinto, Terezinha
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5816116/
https://www.ncbi.nlm.nih.gov/pubmed/29497461
http://dx.doi.org/10.1007/s12247-017-9303-z
Descripción
Sumario:The sterility test described in pharmacopoeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the BacT/Alert® 3D system, is particularly interesting, because it allows a reduced incubation period and lower associated costs. Considering that the BacT/Alert® 3D system offers several culture media formulations developed for this microbial detection system, the present study was aimed to evaluate and compare the performance of BacT/Alert® 3D with the pharmacopoeial sterility test. There was no significant difference between the ability of the culture media to allow detection of microbial contamination. However, the rapid sterility testing method allowed a more rapid detection of the challenge microorganisms, which indicates that the system is a viable alternative for assessing the sterility of injectable products.