Table I.
Acceptance criteria for cord blood platelet concentrate manufacturing
| Type of sample | Parameter | Acceptance criteria |
|---|---|---|
| WCB | Time from collection | <44 hours |
| Signed Informed consent | Present | |
| Volume | 75–150 mL (including CPD) | |
| Visible haemolysis | Absence | |
| Platelet count | ≥150×106/mL | |
| CBPC | Volume | 10 (±5) mL |
| Platelet count | 800–1,200×106/mL | |
| Leukocytes | ≤0.5×106/mL | |
| Erythrocytes | ≤0.1×106/mL | |
| Virology | Negative | |
| Haemoculture | Negative | |
| Maternal blood | Virology | Negative |
WCB: whole cord blood; CPD: citrate-phosphate-dextrose.