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SCHEDULE

PART 4STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS

1.  STORAGE

1.1.  Liquid storage

ComponentTemperature of storageMaximum storage time
Red cell preparations and whole blood (if used for transfusion as whole blood)+2 to +6°C28 to 49 days according to the processes used for collection, processing and storage
Platelet preparations+20 to +24°C5 days, may be stored for 7 days in conjunction with detection or reduction of bacterial contamination
Granulocytes+20 to +24°C24 hours

1.2.  Cryopreservation

ComponentStorage conditions and duration
Red blood cellsUp to 30 years according to processes used for collection, processing and storage
PlateletsUp to 24 months according to processes used for collection, processing and storage
Plasma and cryoprecipitateUp to 36 months according to processes used for collection, processing and storage
Cryopreserved red blood cells and platelets must be formulated in a suitable medium after thawing. The allowable storage period after thawing to depend on the method used.

TRANSPORT AND DISTRIBUTION

2.  Transport and distribution of blood and blood components at all stages of the transfusion chain must be under conditions that maintain the integrity of the product.

ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS

3.1.  Autologous blood and blood components must be clearly identified as such and stored, transported and distributed separately from allogeneic blood and blood components.

3.2.  Autologous blood and blood components must be labelled as required by regulation 8, and, in addition, the label must include the identification of the donor and the warning “FOR AUTOLOGOUS TRANSFUSION ONLY”.