Application of the BacT/ALERTR 3D system for sterility testing of injectable products
Open accessAbstract
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.
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Automated fluorescence-based microbial detection systems such as BacT/Alert detect metabolic activity or CO2 production of microorganisms in culture bottles, providing results within 3-5 days rather than 14 days.
“For example, automated fluorescence-based microbial detection systems, such as BacT/Alert, detect metabolic activity or CO2 production of microorganisms in culture bottles, providing results within 3–5 days rather than 14 days (Lim et al., 2014; Bugno et al., 2015).”
From Isolator-based point-of-care manufacturing: a practical solution for GMP-compliant cell and extracellular vesicles therapy production (2025) · cites this paper as Bugno et al., 2015
The Introduction describes BacT/ALERT 3D as an automated system that detects microbial growth through biochemical or physiological changes, including CO2 production measured colorimetrically—not by fluorescence. The Results and Discussion report faster detection than conventional testing, but do not establish a 3–5-day result time; the Incubation conditions section says both methods were incubated for 14 days. Page numbers are unavailable in our copy. (LLM, conf=0.88)
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Research works printed but not linked: 16
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Chiu, Y.-S., Wang, K.-L., & Wu, K.-L. (2025) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2025.1644318 · Cited by 17 · see citing works
- Authors
- Bugno, A., Lira, R. S., Oliveira, W. A., Almodovar, A. A. B., Saes, D. P. S., & de Jesus Andreoli Pinto, T.
- Affiliations
- Instituto Adolfo Lutz (BR)
- Universidade de São Paulo (BR)
- Corresponding author
- Bugno, Adriana
- ORCID
- Bugno, Adriana
- Venue
- Brazilian Journal of Microbiology
- Publisher
- FapUNIFESP (SciELO)
- Published
- 2015-09
- Volume
- 46
- Issue
- 3
- Pages
- 743-747
- ISSN
- 1517-8382 (ISSN-L)
- 1678-4405
- PMC
- PMC4568852
- OpenAlex
- W2231047138
- Cited by
- 23
- References
- 0
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 2 · 2022: 1 · 2021: 4 · 2020: 1 · 2019: 2 · 2018: 3 · 2017: 2 · 2016: 3
- FWCI
- 2.07
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- Brazilian Journal of Microbiology (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (publishedVersion, other-oa)
- Americanae (AECID Library) (submittedVersion, other-oa)
- Funders
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Topics
- Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Clinical Biochemistry › Bacterial Identification and Susceptibility Testing
- Life Sciences › Immunology and Microbiology › Microbiology › Medical Device Sterilization and Disinfection
- Keywords
- BacT/ALERT 3D, sterility testing, injectable products, parenteral solutions, rapid microbial detection, membrane filtration, microbial contamination
- MeSH terms
- Bacteria, Filtration, Fungi, Microbiological Techniques, Quality Control, Sterilization, Bacterial Load
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