Technology – Plasmapheresis
Our donated blood plasma that 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 Plasmapherese collecting units are within a workshop and classified as the Pharmaceutical Society “Il Ceppo” buildings in which a special air filter system minimizes environmental contamination.
The plasma is collected by a closed system that eliminates the air contact so that contamination from germs and endotoxine contamination is avoided. Each plasma bag is immediately sealed and marked so that each lot gets traceability and cross contamination can be avoided.
Plasmalife is immediately packaged and stored at -20 ° C ± 5 frozen for a minimum period of 90 days (quarantine), while the laboratory tests are carried out to ensure product quality.
Before a horse can be recorded in the group of plasma donors to the society “Il Ceppo”, it is investigated in deep from a climical point of view and is subject to a period of quarantine, which is used to exclude infectious diseases and the presence of hemolysins or hemagglutinins in its blood.
All donors are negative for 19 infectious diseases which are tested during the visit and recording all free from hemolysins and agglutinins against antigens of the major blood groups.
Donors are therefore regarded as “universal ” so that their plasma is generally compatible for all horses, with reduces to a minimum risk of anaphylactic reactions to transfusions.
The strict control of the horse during the entire period while donating plasma ensures the safety and maintenance of the entry conditions.
The attitude of the donor horse is in full respect of their welfare with guaranteed high quality of life.
The quality control program of plasma life encompasses the entire production chain from the beginning of donors selection to finished product.
Donor horses are tested for infectious diseases before each plasma donation, to exclude the possibility of transmission of these diseases completely.
Each plasma part in an independent laboratory test that has been certified by the Italian Ministry of Health to GMP (Good Manufacturing Practice):
– sterility (absence of bacteria, molds and yeasts)
– freedom of endotoxins
– minimum concentration of IgG> = 24 g / l
– Total protein concentration> = 50 g / l
– citrate concentration (excipient / excipient) <= 4.73 g / l