Test | Method | Release criteria | Compliance |
---|---|---|---|
Sterility (aerobic, anaerobic, fungal) | BacT/ALERT, Gram stain | No growth at 7 days | 225/225 |
Endotoxin | Gel Clot | < 0.5 EU/mL | 225/225 |
Mycoplasma | PCR | Negative | 225/225 |
Viability | Trypan blue dye exclusion | ≥ 85% | 225/225 |
BSA | ELISA | No detect | 225/225 |