Use of 27G needles improves sensitivity and performance of ATCC anaerobe reference microorganism detection in BacT/Alert system
| Autor: | Bruno Douradinha, Salvatore Pasqua, Fabio Tuzzolino, Pier Giulio Conaldi, Chiara Di Bartolo, Giampiero Vitale, Danilo D'Apolito, Francesca Cardinale, Anna Pasquariello, Chiara Cusimano |
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| Rok vydání: | 2021 |
| Předmět: |
sterility testing
0301 basic medicine hospital infections lcsh:QH426-470 Serial dilution Microorganism automated blood culture system 03 medical and health sciences 0302 clinical medicine BacT/Alert European Pharmacopoeia Genetics Medicine quality control lcsh:QH573-671 microorganisms Molecular Biology Alert system Syringe Alternative methods lcsh:Cytology business.industry Bact alert method validation Performance results Compendial Method lcsh:Genetics good manufacturing practice 030104 developmental biology 030220 oncology & carcinogenesis Molecular Medicine Original Article Biochemical engineering microbiological contaminations business |
| Zdroj: | Molecular Therapy: Methods & Clinical Development, Vol 20, Iss, Pp 542-550 (2021) Molecular Therapy. Methods & Clinical Development |
| ISSN: | 2329-0501 |
| DOI: | 10.1016/j.omtm.2021.01.010 |
| Popis: | Effective detection of microbiological contaminations present in medicinal cellular products is a crucial step to ensure patients’ safety. In recent decades, several rapid microbiological methods have been developed and validated, but variabilities linked to the use of different resources have led to discordant validation of methods and performance results. Considering this, while developing an in-house BacT/Alert-based method, we evaluated all of the materials used in its validation. Of particular importance, we noticed that the syringe gauge used to inject the samples into the bottles was crucial to obtain robust results. We chose to conduct a comparative test between the BacT/Alert system and the compendial method described in the European Pharmacopoeia, using five dilutions of nine reference microorganism strains and 21G or 27G needles. Our results confirmed that the BacT/Alert system is a valid and faster alternative method to assess sterility of clinical cell therapy products, and that the use of 27G needles increases its sensitivity to detect reference anaerobe microorganisms. Graphical Abstract The BacT/Alert system is used in GMP control activities to test the sterility of ATMPs. The use of 27G needles decreases the TTD of most of the tested microorganisms, when compared to the European Pharmacopeia method, and allows less air intrusion and improves the growth and sensitivity of the method for anaerobic microorganisms. |
| Databáze: | OpenAIRE |
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