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Brazilian Journal of Microbiology

versão impressa ISSN 1517-8382versão On-line ISSN 1678-4405

Resumo

BUGNO, Adriana et al. Application of the BacT/ALERTR 3D system for sterility testing of injectable products. Braz. J. Microbiol. [online]. 2015, vol.46, n.3, pp.743-747. ISSN 1517-8382.  http://dx.doi.org/10.1590/S1517-838246320140587.

Sterility testing as described in the pharmacopoeia compendia requires a 14-day incubation period to obtain an analytical result. Alternative methods that could be applied to evaluating product sterility are especially interesting due to the possibility of reducing this incubation period and thus the associated costs. The aims of this study were to evaluate the performance of the BacT/ALERTR 3D system in detecting microorganisms in large-volume parenteral solutions that were intentionally contaminated and to compare this system to pharmacopoeia sterility testing using the membrane filtration method. The results indicated that there were no significant differences between the methods regarding the ability to detect microbial contamination; however, detection with the BacT/ALERTR 3D system was faster compared to the pharmacopoeia method. Therefore, the BacT/ALERTR 3D system is a viable alternative for assessing the sterility of injectable products.

Palavras-chave : sterility testing; BacT/ALERTR 3D; rapid microbiological method; large-volume parenteral solution.

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