Evaluation of an Amplified ATP Bioluminescence Method for Rapid Sterility Testing of Large Volume Parenteral
Journal of Pharmaceutical Innovation
; 142019.
Article
en En
| LILACS, CONASS, ColecionaSUS, SES-SP, SESSP-IALPROD, SES-SP
| ID: biblio-1425867
Biblioteca responsable:
BR91.2
Ubicación: BR91.2; P
ABSTRACT
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.
Texto completo:
1
Colección SES:
Producao_cientifica
Banco de datos:
CONASS
/
LILACS
/
SES-SP
/
SESSP-IALPROD
/
ColecionaSUS
Asunto principal:
Adenosina Trifosfato
/
Infertilidad
/
Métodos
Idioma:
En
Año:
2019
Tipo del documento:
Article