Mean Limit of Detection of Different Biopharmaceutical Samples
| Microorganism | Average CFU/plate (Range) | ||
|---|---|---|---|
| WFI | Unprocessed Bulk | Finished Bulk | |
| Pseudomonas aeruginosa | 30 (21–37) | 20 (11–28) | 28 (18–36) |
| Staphylococcus aureus | 46 (34–60) | 38 (16–59) | 43 (38–56) |
| Clostridium sporogenes | 23 (12–32) | 31 (19–43) | 36 (22–56) |
| Aspergillus niger | 23 (12–32) | 24 (13–34) | 22 (17–25) |
| Bacillus subtilis | 36 (26–51) | 39 (36–42) | 36 (27–41) |
| Candida albicans | 37 (18–63) | 40 (22–67) | 26 (1–48) |
| Kocuria rhizophila | 28 (3–42) | 19 (11–25) | 18 (3–32) |
| Staphylococcus haemolyticus | 31 (17–45) | 18 (4–45) | 25 (13–37) |
| Penicillium spp | 30 (10–67) | 23 (4–44) | 20 (7–29) |
| Burkholderia cepacia | 33 (31–34) | 29 (28–30) | 29 (28–30) |
| Methylobacterium radiotolerans | 12 (9–15) | 12 (9–15) | 12 (9–15) |
N = 9.