Performance Qualification Criteria
| Procedures | Expected Results | Action As Expected (Yes/No) |
|---|---|---|
| Sensitivity | All strains must be detected. All aerobic strains must be detected in aerobic bottles. All anaerobic strains must be detected in anaerobic bottles. All bacteria, yeast, and mold must be detected. | Yes |
| Ruggedness | All strains must be detected by different analysts. | Yes |
| Time of detection | All microorganisms are detected within 14 days. | Yes |
| Equivalency (with and without spiking) | Alternative method must show equivalent results to the compendial. | Yes |
| Repeatability | All replicates inoculated with organisms are determined to be positive. | Yes |
| Limits of Detection | a. Each challenge organism must be detected at less than 100 CFU but greater than 0 CFU between 3 analysts. b. Microorganisms must be detected at less than 5 CFU using serial dilutions in biopharmaceutical samples. | Yes |