- Title
- Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test
- Creator
- Bugno, Adriana; Saes, Deborah Pita Sances; Almodovar, Adriana Aparecida Buzzo; Dua, Kamal; Awasthi, Rajendra; Ghisleni, Daniela Dal Molim; Hirota, Marici Tiomi; de Oliveira, Wesley Anderson; de Jesus Andreoli Pinto, Terezinha
- Relation
- Journal of Pharmaceutical Innovation Vol. 13, Issue 1, p. 27-35
- Publisher Link
- http://dx.doi.org/10.1007/s12247-017-9303-z
- Publisher
- Springer
- Resource Type
- journal article
- Date
- 2018
- Description
- 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.
- Subject
- rapid microbiological method; culture media; sterility test; sterility testing performance
- Identifier
- http://hdl.handle.net/1959.13/1448223
- Identifier
- uon:43349
- Identifier
- ISSN:1872-5120
- Language
- eng
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