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The Blood Safety and Quality Regulations 2005
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PART 5QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS
1. THE BLOOD COMPONENTS
| 1. Red cell preparations | The components listed in points 1.1 to 1.8 may be further processed within blood establishments and must be labelled accordingly |
| 1.1 | Red cells |
| 1.2 | Red cells, buffy coat removed |
| 1.3 | Red cells, leucocyte-depleted |
| 1.4 | Red cells, in additive solution |
| 1.5 | Red cells, buffy coat removed, in additive solution |
| 1.6 | Red cells, leucocyte-depleted, in additive solution |
| 1.7 | Red cells, apheresis |
| 1.8 | Whole blood |
| 2. Platelet preparations | The components listed in points 2.1 to 2.6 may be further processed within blood establishments and must be labelled accordingly |
| 2.1 | Platelets, apheresis |
| 2.2 | Platelets, apheresis, leucocyte-depleted |
| 2.3 | Platelets, recovered, pooled |
| 2.4 | Platelets, recovered, pooled, leucocyte-depleted |
| 2.5 | Platelets, recovered, single unit |
| 2.6 | Platelets, recovered, single unit, leucocyte-depleted |
| 3. Plasma preparations | The components listed in 3.1 to 3.3 may be further processed within blood establishments and must be labelled accordingly |
| 3.1 | Fresh-frozen plasma |
| 3.2 | Fresh-frozen plasma, cryoprecipitate-depleted |
| 3.3 | Cryoprecipitate |
| 4. | Granulocytes, apheresis |
2. QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS
2.1. Blood and blood components must comply with the following technical quality measurements and meet the acceptable results.
2.2. Appropriate bacteriological control of the collection and manufacturing process must be performed.
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 | 6.4 -7.4 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 | 6.4-7.4 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 | 6.4-7.4 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 | 6.4-7.4 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 | 6.4-7.4 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 | 6.4-7.4 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 |
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