Bacteriostasis and Fungistasis Testing of Biopharmaceutical Product B 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 = 4 | |
| Aspergillus niger | 2.01 (0.04) | 2.06 (0.08) | 25 |
| Bacillus subtilis | 0.68 (0.02) | 0.69 (0.02) | 42 |
| Pseudomonas aeruginosa | 0.77 (0.02) | 0.77 (0.01) | 29 |
| Candida albicans | 1.50 (0.01) | 1.55 (0.11) | 46 |
| Clostridium sporogenes | 0.87 (0.02) | 0.84 (0.01) | 32 |
| Staphylococcus aureus | 0.79 (0.01) | 0.79 (0.01) | 54 |