Bacteriostasis and Fungistasis Testing of Biopharmaceutical Product A Using the BacT/ALERT®
| Microorganism | Mean Time to Detection for Samples (Days) (Standard Deviation) | Mean Time to Detection for Positive Controls (Days) (Standard Deviation) | Average Inoculum (CFU) |
|---|---|---|---|
| N = 3 | N = 3 | N = 3 | |
| Aspergillus niger | 2.07 (0.16) | 2.02 (0.05) | 24 |
| Bacillus subtilis | 0.71 (0.01) | 0.70 (0.01) | 31 |
| Pseudomonas aeruginosa | 0.82 (0.02) | 0.82 (0.01) | 23 |
| Candida albicans | 2.03 (0.16) | 2.02 (0.03) | 36 |
| Clostridium sporogenes | 0.91 (0.04) | 0.86 (0.01) | 25 |
| Staphylococcus aureus | 0.79 (0.03) | 0.80 (0.02) | 43 |