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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 preparationsThe components listed in points 1.1 to 1.8 may be further processed within blood establishments and must be labelled accordingly
1.1Red cells
1.2Red cells, buffy coat removed
1.3Red cells, leucocyte-depleted
1.4Red cells, in additive solution
1.5Red cells, buffy coat removed, in additive solution
1.6Red cells, leucocyte-depleted, in additive solution
1.7Red cells, apheresis
1.8Whole blood
2. Platelet preparationsThe components listed in points 2.1 to 2.6 may be further processed within blood establishments and must be labelled accordingly
2.1Platelets, apheresis
2.2Platelets, apheresis, leucocyte-depleted
2.3Platelets, recovered, pooled
2.4Platelets, recovered, pooled, leucocyte-depleted
2.5Platelets, recovered, single unit
2.6Platelets, recovered, single unit, leucocyte-depleted
3. Plasma preparationsThe components listed in 3.1 to 3.3 may be further processed within blood establishments and must be labelled accordingly
3.1Fresh-frozen plasma
3.2Fresh-frozen plasma, cryoprecipitate-depleted
3.3Cryoprecipitate
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.

ComponentQuality measures requiredAcceptable results for quality measures
The required frequency of sampling for all measurements shall be determined using statistical process control
Red cellsVolumeValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis
Haemoglobin (*)Not less than 45g per unit
HaemolysisLess than 0.8% of red cell mass at end of the shelf life
Red cells, buffy coat removedVolumeValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis
Haemoglobin (*)Not less than 43 g per unit
HaemolysisLess than 0.8% of red cell mass at the end of the shelf life
Red cells, leucocyte-depletedVolumeValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis
Haemoglobin (*)Not less than 40g per unit
Leucocyte contentLess than 1 x 106 per unit
HaemolysisLess than 0.8% of red cell mass at the end of the shelf life
Red cells, in additive solutionVolumeValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis
Haemoglobin (*)Not less than 45g per unit
HaemolysisLess than 0.8% of red cell mass at end of the shelf life
Red cells, buffy coat removed, in additive solutionVolumeValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis
Haemoglobin (*)Not less than 43g per unit
HaemolysisLess than 0.8% of red cell mass at the end of the shelf life
Red cells, leucocyte-depleted, in additive solutionVolumeValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis
Haemoglobin (*)Not less than 40g per unit
Leucocyte contentLess than 1 x 106 per unit
HaemolysisLess than 0.8% of red cell mass at the end of the shelf life
Red cells, apheresisVolumeValid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis
Haemoglobin (*)Not less than 40g per unit
HaemolysisLess than 0.8% of red cell mass at the end of the shelf life
Whole bloodVolume

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
HaemolysisLess than 0.8% of red cell mass at the end of the shelf life
Platelets, apheresisVolumeValid for storage characteristics to maintain product within specifications for pH
Platelet contentVariations in platelet content per single donation are permitted within the limits that comply with validated preparation and preservation conditions
pH6.4 -7.4 corrected for 22°C, at the end of the shelf life
Platelets, apheresis, leucocyte-depletedVolumeValid for storage characteristics to maintain product within specifications for pH
Platelet contentVariations in platelet content per single donation are permitted within the limits that comply with validated preparation and preservation conditions
Leucocyte contentLess than 1 x 106 per unit
pH6.4-7.4 corrected for 22°C, at the end of the shelf life
Platelets, recovered, pooledVolumeValid for storage characteristics to maintain product within specifications for pH
Platelet contentVariations 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)

pH6.4-7.4 corrected for 22°C, at the end of the shelf life
Platelets, recovered, pooled, leucocyte-depletedVolumeValid for storage characteristics to maintain product within specifications for pH
Platelet contentVariations in platelet content per pool are permitted within limits that comply with validated preparation and preservation conditions
Leucocyte contentLess than 1 x 106 per pool
pH6.4-7.4 corrected for 22°C, at the end of the shelf life
Platelets, recovered, single unitVolumeValid for storage characteristics to maintain product within specifications for pH
Platelet contentVariations 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)

pH6.4-7.4 corrected for 22°C, at the end of the shelf life
Platelets, recovered, single unit, leucocyte-depletedVolumeValid for storage characteristics to maintain product within specifications for pH
Platelet contentVariations in platelet content per single unit are permitted within limits that comply with validated preparation and preservation conditions
Leucocyte contentLess than 1 x 106 per unit
pH6.4-7.4 corrected for 22°C, at the end of the shelf life
Plasma, fresh-frozenVolumeStated volume +/- 10%
Factor VIIIc(*)Average (after freezing and thawing): 70% or more of the value of the freshly collected plasma unit
Total proteinNot 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-depletedVolumeStated 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

CryoprecipitateFribrinogen content(*)Greater than or equal to 140mg per unit
Fractor VIIIc content (*)Greater than or equal to 70 international units per unit
Granulocytes, apheresisVolumeLess than 500ml
Granulocyte contentGreater than 1 x 1010 granulocytes per unit

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