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Use of 27G needles improves sensitivity and performance of ATCC anaerobe reference microorganism detection in
Salvatore Pasqua1, Giampiero Vitale1, Anna Pasquariello2
1Unità Prodotti Cellulari (GMP), Fondazione Ri.MED c/o IRCCS-ISMETT (Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione), Via E. Tricomi 5, 90127 Palermo, Italy.
Abstract:
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.
Insights
This study found that the BacT/Alert system is a faster method for detecting microbial contamination in cell therapies. Using finer 27G needles improved the detection of anaerobic microorganisms, enhancing patient safety.
Area of Science:
- Microbiology
- Cellular Therapy
- Pharmaceutical Science
Background:
- Ensuring patient safety in cell therapy requires effective detection of microbiological contamination.
- Variability in validation resources has led to inconsistent results for rapid microbiological methods.
- Developing robust in-house methods is essential for reliable sterility testing.
Purpose of the Study:
- To validate an in-house BacT/Alert-based method for detecting microbial contamination in medicinal cellular products.
- To evaluate the impact of different validation materials, specifically syringe gauge, on method performance.
- To compare the BacT/Alert system with the European Pharmacopoeia compendial method.
Main Methods:
- Comparative analysis of the BacT/Alert system against the European Pharmacopoeia compendial method.
- Testing with five dilutions of nine reference microorganism strains.
- Evaluation of two syringe gauges (21G and 27G) for sample injection.
Main Results:
- The BacT/Alert system demonstrated comparable performance to the compendial method.
- The BacT/Alert system offers a faster alternative for sterility assessment of cell therapy products.
- Utilizing 27G needles significantly increased the sensitivity for detecting reference anaerobic microorganisms.
Conclusions:
- The BacT/Alert system is a validated and efficient alternative for sterility testing of clinical cell therapy products.
- Syringe gauge is a critical factor influencing the sensitivity of microbiological detection methods.
- The use of 27G needles enhances the BacT/Alert system's capability to detect anaerobic contaminants.
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