Division 2.4
United Kingdom
For autologous donations, the measures marked with an asterisk (*) are recommendations only.
| Component | Quality measurements required The required frequency of sampling for all measurements shall be determined using statistical process control | Acceptable results for quality measurements |
|---|---|---|
| Red cells | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 45 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, buffy coat removed | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 43 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, leucocyte-depleted | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 40 g per unit | |
| Leucocyte content | Less than 1 × 106 per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, in additive solution | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 45 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, buffy coat removed, in additive solution | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 43 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, leucocyte-depleted, in additive solution | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 40 g per unit | |
| Leucocyte content | Less than 1 × 106 per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Red cells, apheresis | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 40 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Whole blood | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis 450 ml +/- 50ml For paediatric autologous whole blood collections — not to exceed 10,5 ml per kg body weight |
| Haemoglobin (*) | Not less than 45 g per unit | |
| Haemolysis | Less than 0,8 % of red cell mass at the end of the shelf life | |
| Platelets, apheresis | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per single donation are permitted within limits that comply with validated preparation and preservation conditions | |
| pH | F1Minimum 6,4 corrected for 22 °C, at the end of the shelf life | |
| Platelets, apheresis, leucocyte-depleted | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per single donation are permitted within limits that comply with validated preparation and preservation conditions | |
| Leucocyte content | Less than 1 × 106 per unit | |
| pH | Minimum 6,4 corrected for 22 °C, at the end of the shelf life | |
| Platelets, recovered, pooled | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per pool are permitted within limits that comply with validated preparation and preservation conditions | |
| Leucocyte content | Less than 0,2 × 109 per single unit (platelet-rich plasma method) Less than 0,05 × 109 per single unit (buffy coat method) | |
| pH | Minimum 6,4 corrected for 22 °C, at the end of the shelf life | |
| Platelets, recovered, pooled, leucocyte-depleted | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per pool are permitted within limits that comply with validated preparation and preservation conditions | |
| Leucocyte content | Less than 1 × 106 per pool | |
| pH | Minimum 6,4 corrected for 22 °C, at the end of the shelf life | |
| Platelets, recovered, single unit | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per single unit are permitted within limits that comply with validated preparation and preservation conditions | |
| Leucocyte content | Less than 0,2 × 109 per single unit (platelet-rich plasma method) Less than 0,05 × 109 per single unit (buffy coat method) | |
| pH | Minimum 6,4 corrected for 22 °C, at the end of the shelf life | |
| Platelets, recovered, single unit, leucocyte-depleted | Volume | Valid for storage characteristics to maintain product within specifications for pH |
| Platelet content | Variations in platelet content per single unit are permitted within limits that comply with validated preparation and preservation conditions | |
| Leukocyte content | Less than 1 × 106 per unit | |
| pH | Minimum 6,4 corrected for 22 °C, at the end of the shelf life | |
| Plasma, fresh-frozen | Volume | Stated volume +/- 10 % |
| Factor VIIIc (*) | Average (after freezing and thawing): 70 % or more of the value of the freshly collected plasma unit | |
| Total protein (*) | Not less than 50 g/l | |
| Residual cellular content (*) | Red cells: less than 6,0 × 109/l Leucocytes: less than 0, 1 × 109/l Platelets: less than 50 × 109/l | |
| Plasma, fresh-frozen, cryoprecipitate-depleted | Volume | Stated volume: +/- 10 % |
| Residual cellular content (*) | Red cells: less than 6,0 × 109/l Leucocytes: less than 0,1 × 109/l Platelets: less than 50 × 109/l | |
| Cryoprecipitate | Fibrinogen content (*) | Greater than or equal to 140 mg per unit |
| Factor VIIIc content (*) | Greater than or equal to 70 international units per unit | |
| Granulocytes, apheresis | Volume | Less than 500 ml |
| Granulocyte content | Greater than 1 × 1010 granulocytes per unit |