We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Fungal detection using BacT/ALERT DUAL-T while sterility testing of pharmaceutical products.
- Authors
Sakhno, N. G.; Gunar, O. V.; Roshchina, M. V.
- Abstract
The development of rapid, accurate and reliable methods to detect mold in medicinal products is an important challenge, especially for sterility testing. The objective of this study was to optimise fungal detection using the BacT/ALERT 3D DUAL-T microbial detection system with a maximum of 7 days of incubation. The influence of incubation temperature and culture medium was investigated. A total of four Aspergillus spp. and one Penicillium spp. were used in this study. The comparison of parameters, such as limit of detection (LOD), time to detection (TTD) and inoculation techniques, was carried out. The data demonstrated that the BacT/ALERT 3D DUAL-T system and the compendia method revealed similar LOD. The most appropriate culture medium bottle was iLYM. Venting of this medium prior to use decreased the TTD although this difference was not significant. The length of venting time had no effect on fungal growth.
- Subjects
PHARMACEUTICAL industry; FUNGAL growth; DETECTION limit; MYCOSES; MEDICAL care
- Publication
European Journal of Parenteral & Pharmaceutical Sciences, 2019, Vol 24, Issue 1, p6
- ISSN
1740-6277
- Publication type
Article