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procedure should ensure the separation of components that have not been irradiated from those that have been irradiated, and should ensure they have
distinctive labelling.
9.4.3
Blood and blood components
Blood components may be obtained using the methods described in section 9.4.2. However, the sequence and the combination of the methods used in
the production of blood components may vary from one product to another.
The collection process itself is already crucial for the quality of blood components. Measures such as a reliable arm-cleaning and disinfection
procedure, the use of closed and sterile collection systems, and appropriate microbiological controls should be implemented. Time limits should be
defi ned for the processing of blood components.
There are detailed recommendations concerning the preparation and quality assurance of blood components. See for instance Guide to the preparation,
use and quality assurance of blood components of the Council of Europe 13. In the following sections, examples of the most important blood
components are described. Where NRA requirements exist, they should be followed. Specifi cations of a number of products are described below.
9.4.3.1 Whole blood
Whole blood for transfusion is blood that is taken from a donor who has been assessed and found suitable as meeting the blood establishment and
NRA acceptance criteria. Whole blood is collected in sterile and pyrogen- free containers with a suitable anticoagulant. It may be used without further
processing. In some cases, whole blood for transfusion may also be used after leukocyte reduction.
The temperature of whole blood stored for transfusion should remain controlled between 1° and 6°C or in a more stringent range defi ned by the
NRA. The storage time depends on the anticoagulantpreservative solution used.
Periodic quality control should be performed on the fi nal product to ensure that the manufacturing process is consistent see 9.6. At a minimum, the
following critical parameters should be checked during the quality control assays:
— volume; — haemoglobin or haematocrit;
— haemolysis at the end of storage.
The primary use of whole blood is as a source material for the preparation of blood components. Transportation and further manufacturing processes
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should be developed to maximize the number of components that may be produced from a whole blood donation. After collection, whole blood should
be kept at a controlled temperature appropriate to the intended component manufacture and should be delivered to the production site as quickly as
possible. If whole blood is collected away from the production site, the validated transport systems should ensure that correct temperatures are
maintained throughout the process and that the product is delivered within 24 hours. The period between collection and further processing depends on
the product but should not exceed 24 hours.
The whole blood may also be fi ltrated to reduce leukocyte content prior to further processing.
Components should be manufactured by a method validated as meeting the predefi ned product specifi cations.
9.4.3.2 Red-cell concentrate
Red-cell concentrates are obtained from whole blood by centrifugation and removal of plasma with or without buffy coat, depending on the centrifugation
parameters. After subsequent addition of an appropriate nutrient solution, the red cells should be stored at 1–6°C as soon as possible. Alternatively,
red-cell concentrates may be obtained using an apheresis system and likewise stored at 1–6°C. Red-cell units that exceed 10°C after reaching the
storage temperature should be discarded. The red-cell concentrate may be used for transfusion without further processing.
To obtain leukocyte-reduced red-cell concentrates, either whole blood fi ltration can be applied prior to separation or there can be a post-separation fi ltration of
the red-cell concentrate. A fully validated procedure should be established to determine optimum conditions for use of a leukocyte reduction method.
Red-cell concentrates are stored under the same storage conditions as whole blood. The storage time depends on the anticoagulantpreservative solution
used.
Further methods of preparation, such as irradiation or washing, are applied to obtain specifi c red-cell products, depending on the clinical indication.
Periodic quality control should be performed on the fi nal product to ensure that the manufacturing process is consistent see 9.6. Parameters measured depend
on the type of red-cell concentrate product obtained. At a minimum, the following critical parameters should be checked during the quality control assays:
— volume; — haemoglobin or haematocrit;
— haemolysis at the end of storage; — residual leukocytes, if leukocyte reduction is performed.
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9.4.3.3 Platelet concentrate
