Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test |
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| Authors: | Adriana Bugno Deborah Pita Sanches Saes Adriana Aparecida Buzzo Almodovar Kamal Dua Rajendra Awasthi Daniela Dal Molim Ghisleni Marici Tiomi Hirota Wesley Anderson de Oliveira Terezinha de Jesus Andreoli Pinto |
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| Affiliation: | 1.Adolfo Lutz Institute,S?o Paulo,Brazil;2.Discipline of Pharmacy, Graduate School of Health,University of Technology Sydney,Sydney,Australia;3.School of Pharmacy and Biomedical Sciences,The University of Newcastle,Callaghan,Australia;4.School of Pharmaceutical Sciences,Shoolini University,Solan,India;5.NKBR College of Pharmacy & Research Centre,Meerut,India;6.S?o Paulo University,S?o Paulo,Brazil |
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| 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. |
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