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. 2018;13(1):27-35.
doi: 10.1007/s12247-017-9303-z. Epub 2017 Dec 5.

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

Adriana Bugno  1 , Deborah Pita Sanches Saes  1 , Adriana Aparecida Buzzo Almodovar  1 , Kamal Dua  2   3   4 , Rajendra Awasthi  5 , Daniela Dal Molim Ghisleni  6 , Marici Tiomi Hirota  1 , Wesley Anderson de Oliveira  6 , Terezinha de Jesus Andreoli Pinto  6
Affiliations

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

Adriana Bugno et al. J Pharm Innov. 2018.

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.

Keywords: Culture media; Rapid microbiological method; Sterility test; Sterility testing performance.

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Figures

Fig. 1
Fig. 1
Distribution of the positive results for each level of contamination according to the methodology employed
Fig. 2
Fig. 2
Mean time required to detect microbial growth for each of the methodology employed
See this image and copyright information in PMC

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