Evaluation of an Amplified ATP Bioluminescence Method for Rapid Sterility Testing of Large Volume Parenteral
Journal of Pharmaceutical Innovation
; 142019.
Article
in English
| LILACS, CONASS, Coleciona SUS, Sec. Est. Saúde SP, SESSP-IALPROD, Sec. Est. Saúde SP
| ID: biblio-1425867
Responsible library:
BR91.2
Localization: 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.
Full text:
Available
Collection:
National databases
/
Brazil
Database:
CONASS
/
LILACS
/
Sec. Est. Saúde SP
/
SESSP-IALPROD
/
Coleciona SUS
Main subject:
Adenosine Triphosphate
/
Infertility
/
Methods
Language:
English
Journal:
Journal of Pharmaceutical Innovation
Year:
2019
Document type:
Article
Institution/Affiliation country:
Amity Institute of Pharmacy/BR
/
Department of Pharmacy/BR
/
Department of PharmacyProfessor/BR
/
Discipline of Pharmacy, Graduate School of Health/BR
/
Institute Adolfo Lutz/BR