- Title
- Evaluation of an amplified ATP bioluminescence method for rapid sterility testing of large volume parenteral
- Creator
- Bugno, Adriana; Almodovar, Adriana Aparecida Buzzo; Saes, Deborah Pita Sanches; Awasthi, Rajendra; Ghisleni, Daniela Dal Molim; de Souza Braga, Marina; de Oliveira, Wesley Anderson; Dua, Kamal; de Jesus Andreoli Pinto, Terezinha
- Relation
- Journal of Pharmaceutical Innovation Vol. 14, Issue 2, p. 152-158
- Publisher Link
- http://dx.doi.org/10.1007/s12247-018-9344-y
- Publisher
- Springer
- Resource Type
- journal article
- Date
- 2019
- Description
- The sterility test described in pharmacopeial 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 Celsis AKuScreen™ Advance™ system, is particularly interesting because it allows a reduced incubation period and higher efficiency. The present study was aimed to evaluate and compare the performance of Celsis AKuScreen™ Advance™ system with the pharmacopeial sterility test. There was no significant difference between the ability of detection of microbial contamination observed within pharmacopeial method and test method. The Celsis AKuScreen™ Advance™ system allowed a faster detection of the challenge microorganisms, which indicates that the system is a viable alternative for assessing the sterility of injectable products.
- Subject
- Celsis AKuScreen™ Advance™; performance; rapid microbiological method; sterility test
- Identifier
- http://hdl.handle.net/1959.13/1442962
- Identifier
- uon:41845
- Identifier
- ISSN:1872-5120
- Language
- eng
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