Paragraph 2.3
For autologous donations, the measures marked with an asterisk (*) are recommendations only.
| Component | Quality measures required | Acceptable results for quality measures |
|---|---|---|
| The required frequency of sampling for all measurements shall be determined using statistical process control | ||
| Red cells | Volume | Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis |
| Haemoglobin (*) | Not less than 45g per unit | |
| Haemolysis | Less than 0.8% of red cell mass at 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 40g per unit | |
| Leucocyte content | Less than 1 x 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 45g per unit | |
| Haemolysis | Less than 0.8% of red cell mass at 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 43g 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 40g per unit | |
| Leucocyte content | Less than 1 x 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 40g 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 450ml +/- 50ml For paediatric autologous whole blood collections – not to exceed 10.5ml per kg body weight |
| Haemoglobin (*) | Not less than 45g 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 the 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 the limits that comply with validated preparation and preservation conditions | |
| Leucocyte content | Less than 1 x 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 x 109 per single unit (platelet-rich plasma method) Less than 0.05 x 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 x 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 x 109 per single unit (platelet-rich plasma method) Less than 0.05 x 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 | |
| Leucocyte content | Less than 1 x 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 50g/l | |
| Residual cellular content(*) | Red cells: less than 6.0 x 109/l Leucocytes: less than 0.1 x 109/l Platelets: less than 50 x 109/l | |
| Plasma, fresh-frozen, cryoprecipitate-depleted | Volume | Stated volume +/-10% |
| Residual cellular content(*) | Red cells: less than 6.0 x 109/l Leucocytes: less than 0.1 x 109/l Platelets: less than 50 x 109/l | |
| Cryoprecipitate | Fribrinogen content(*) | Greater than or equal to 140mg per unit |
| Fractor VIIIc content (*) | Greater than or equal to 70 international units per unit | |
| Granulocytes, apheresis | Volume | Less than 500ml |
| Granulocyte content | Greater than 1 x 1010 granulocytes per unit |
Annotations
Textual amendments
- F1
Words in Sch. Pt. 5 para. 2 Table substituted (18.7.2016) by The Blood Safety and Quality (Amendment) Regulations 2016 (S.I. 2016/604), regs. 1, 2(3)