Technology – Plasmapheresis
Our plasma is collected in special machines with a closed collecting system by sterile disposable kits, it is separated by tangential filtration of the blood cells (erythrocytes, leukocytes and platelets) through the process of plasmapheresis and the plasma is collected directly into the transfusion bag.
The Plasmapheresis collecting units are within a classified workshop in the Pharmaceutical Society “Plasmalife ltd” buildings, in which a special air filter system minimizes environmental contamination.
The plasma is collected within a closed system that eliminates the air contact so that contamination from germs and endotoxins is avoided. Each plasma bag is immediately sealed and marked so that each lot gets traceability.
Plasmalife Horse® is immediately packaged and stored at -20 ° C ± 5 for a minimum period of 90 days (quarantine), while the laboratory tests are carried out to ensure the product quality.
Before a horse can be assigned in the group of plasma donors of our society “PlasmaLife ltd”, they are thoroughly checked from a clinical point of view and are subjected to a period of quarantine, which is used to exclude infectious diseases and the presence of hemolysins or hemagglutinins against antigens of the major blood groups.
Donors are therefore regarded as “universal” so that their plasma is generally compatible for all horses, which reduces to a minimum the risk of anaphylactic reactions to transfusions.
The strict control of the horse during the entire period of donation ensures the safety and maintenance of the entry conditions.
The management of the donors is in full respect of their welfare with a guaranteed high quality of life.
The quality control program of Plasmalife Horse® encompasses the entire production chain from the beginning of the donors selection to the finished product.
Donors are tested for infectious diseases before each plasma donation, to completely exclude the possibility of transmission of these diseases.
Each batch is tested in an independent laboratory that has been certified by the Italian Ministry of Health as GMP (Good Manufacturing Practice).
They are tested for:
– sterility (absence of bacteria, molds and yeasts)
– freedom from endotoxins
– minimum concentration of IgG > = 24 g / l
– Total protein concentration > = 50 g / l
– citrate concentration (excipient / excipient) <= 4.73 g / l