Component | Quality measurements required The required frequency of sampling for all measurements shall be determined using statistical process control | Acceptable results for quality measurements |
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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
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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 | [Minimum 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
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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
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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 |