title: Application of the BacT/ALERTR 3D system for sterility testing of injectable products.
abstract: 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/ALERT(R) 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/ALERT(R) 3D system was faster compared to the pharmacopoeia method. Therefore, the BacT/ALERT(R) 3D system is a viable alternative for assessing the sterility of injectable products.
authors.affiliation: Centro de Medicamentos, Cosméticos e Saneantes, Instituto Adolfo Lutz, São Paulo, SP, Brazil .
authors.forename: Adriana
authors.initials: A
authors.lastname: Bugno
authors.affiliation: Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, Brazil .
authors.forename: Rodolfo Santos
authors.initials: RS
authors.lastname: Lira
authors.affiliation: Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, Brazil .
authors.forename: Wesley Anderson
authors.initials: WA
authors.lastname: Oliveira
authors.affiliation: Centro de Medicamentos, Cosméticos e Saneantes, Instituto Adolfo Lutz, São Paulo, SP, Brazil .
authors.forename: Adriana Aparecida Buzzo
authors.initials: AA
authors.lastname: Almodovar
authors.affiliation: Centro de Medicamentos, Cosméticos e Saneantes, Instituto Adolfo Lutz, São Paulo, SP, Brazil .
authors.forename: Deborah Pita Sanches
authors.initials: DP
authors.lastname: Saes
authors.affiliation: Faculdade de Ciências Farmacêuticas, Universidade de São Paulo, São Paulo, SP, Brazil .
authors.forename: Terezinha de Jesus Andreoli
authors.initials: Tde J
authors.lastname: Pinto
mesh_terms: D001419:Bacteria / Q000254:growth & development / Q000302:isolation & purification*; D058491:Bacterial Load; D005374:Filtration / Q000379:methods; D005658:Fungi / Q000254:growth & development / Q000302:isolation & purification*; D008828:Microbiological Techniques / Q000379:methods*; D011786:Quality Control; D013242:Sterilization
keywords: BacT/ALERTR 3D; large-volume parenteral solution; rapid microbiological method; sterility testing