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PubMed Central
Article . 2015
License: CC BY NC
Data sources: PubMed Central
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Application of the BacT/ALERTR 3D system for sterility testing of injectable products.

Authors: Bugno, Adriana; Lira, Rodolfo Santos; Oliveira, Wesley Anderson; Almodovar, Adriana Aparecida Buzzo; Saes, Deborah Pita Sanches; de Jesus Andreoli Pinto, Terezinha;

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.

Keywords

sterility testing, Microbiological Techniques, Quality Control, Bacteria, Fungi, Sterilization, Bacterial Load, rapid microbiological method, Environmental Microbiology, large-volume parenteral solution, BacT/ALERTR 3D, Filtration

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    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
16
Top 10%
Top 10%
Top 10%
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