| Autor: |
Bugno A; 1Adolfo Lutz Institute, 355 Dr. Arnaldo Avenue, São Paulo, 01246-000 Brazil., Saes DPS; 1Adolfo Lutz Institute, 355 Dr. Arnaldo Avenue, São Paulo, 01246-000 Brazil., Almodovar AAB; 1Adolfo Lutz Institute, 355 Dr. Arnaldo Avenue, São Paulo, 01246-000 Brazil., Dua K; 2Discipline of Pharmacy, Graduate School of Health, University of Technology Sydney, Sydney, NSW 2007 Australia.; 3School of Pharmacy and Biomedical Sciences, The University of Newcastle, Newcastle, Callaghan, NSW 2308 Australia.; 4School of Pharmaceutical Sciences, Shoolini University, Solan, Himachal Pradesh 173229 India., Awasthi R; NKBR College of Pharmacy & Research Centre, Meerut, Uttar Pradesh 245206 India., Ghisleni DDM; 6São Paulo University, Avenida Professor Lineu Prestes, 580, São Paulo, 05508-000 Brazil., Hirota MT; 1Adolfo Lutz Institute, 355 Dr. Arnaldo Avenue, São Paulo, 01246-000 Brazil., de Oliveira WA; 6São Paulo University, Avenida Professor Lineu Prestes, 580, São Paulo, 05508-000 Brazil., de Jesus Andreoli Pinto T; 6São Paulo University, Avenida Professor Lineu Prestes, 580, São Paulo, 05508-000 Brazil. |
| Abstrakt: |
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. |
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