Criticality Assessment for Microbial Safety Concerns
| Attributes | Severity | Uncertainty | Detectability |
|---|---|---|---|
| Bacterial endotoxins | High | Low | Analytical methods have a high sensitivity |
| Sterility | High | Low | Compendial methods are growth-based with at least a 14 day incubation |
| Mycoplasma | Moderate–High | Low | Sensitivity at least 10 CFU/mL |
| Adventitious viruses | High | Low | Detection methods sensitive but highly specific |