These guidelines provide a framework on which Blood Establishments should assemble standard operating procedures (SOPs) for the manufacture of blood components.
These guidelines apply to single-donor and small-pool components (<12 donors) prepared from units of whole blood or by apheresis.
Blood Establishments should ensure that the hospital blood banks that they supply are informed of these component production guidelines, and should consult with them on proposed changes to existing component processing and on the adoption of new components.
Technologies for pathogen inactivation of blood components are now being used in Europe. Within the UK, methylene blue treated plasma and the medicinal product solvent detergent treated pooled plasma are in use. Treatment of plasma and of platelets with amotosalen ultraviolet (UV) treatment or riboflavin UV treatment is CE marked and may be used in the UK in the future. Specifications for these and similar products will be considered as and when they are adopted. At present no CE-marked technology exists for pathogen inactivation of red cells, although some companies are working on suitable approaches.
Filters suitable for the removal of abnormal prion from red cells have been CE marked and have been under clinical assessment in the UK. Recommendations on their use have recently been submitted to ministers and the outcome on this is awaited. As part of the validation and clinical assessment, specifications for these products have been drafted and are available in the Trial component (Annex 3) section of the online version of these guidelines.1