Detection of Microorganisms in Biopharmaceutical Samples Using the BacT/ALERT® by Three Different Analysts
| Microorganisms | Mean Time to Detection in Days (Range) (SD**) | ||||
|---|---|---|---|---|---|
| Water for Injection | Unprocessed Bulk | Finished Bulk | Total Average | Total Standard Deviation | |
| (n = 3) | (n = 3) | (n = 3) | (n = 9) | (n = 9) | |
| Pseudomonas aeruginosa | 0.78 (0.75–0.81) (0.03) | 0.80 (0.79–0.81) (0.80) | 0.76 (0.75–0.78) (0.02) | 0.78 | 0.02 |
| Staphylococcus aureus | 0.78 (0.76–0.80) (0.02) | 0.76 (0.72–0.78) (0.04) | 0.76 (0.76–0.80) (0.01) | 0.76 | 0.02 |
| Clostridium sporogenes | 0.96 (0.92–0.99) (0.04) | 0.91 (0.84–0.96) (0.06) | 0.98 (0.88–1.04) (0.09) | 0.95 | 0.06 |
| Aspergillus niger | 1.87 (1.75–2.00) (0.13) | 1.58 (1.41–1.84) (0.23) | 1.97 (1.87–2.04) (0.09) | 1.81 | 0.22 |
| Bacillus subtilis | 0.64 (0.63–0.65) (0.01) | 0.66 (0.65–0.66) (0.01) | 0.65 (0.63–0.67) (0.02) | 0.65 | 0.01 |
| Candida albicans | 1.47 (1.32–1.65) (0.17) | 2.91 (2.52–3.42) (0.46) | 2.47 (2.17–2.99) (0.44) | 2.28 | 0.72 |
| Kocuria rhizophila | 1.57 (1.40–1.67) (0.15) | 2.29 (2.18–2.36) (0.09) | 1.97 (1.85–2.04) (0.11) | 1.94 | 0.33 |
| Staphylococcus haemolyticus | 0.95 (0.92–0.98) (0.03) | 0.97 (0.94–1.00) (0.03) | 0.97 (0.94–0.99) (0.03) | 0.96 | 0.03 |
| Penicillium spp | 1.01 (0.53–1.94) (0.80) | 0.59 (0.55–0.65) (0.05) | 1.00 (0.57–1.60) (0.53) | 0.87 | 0.5 |
| Burkholderia cepacia* | 0.96 (0.95–0.97) (0.01) | 1.07 (1.04–1.09) (0.03) | 1.13 (1.10–1.20) (0.06) | 1.05 | 0.08 |
| Methylobacterium radiotolerans* | 4.31 (4.25–4.35) (0.05) | 6.24 (5.35–6.7) (0.77) | 6.50 (6.41–6.64) (0.13) | 5.77 | 1.11 |