The Octapharma Quality Plasma System comprises:
Selection of healthy donors
All donors are interviewed with regard to their medical and lifestyle history, and are only accepted for donation if they are healthy and free of risks for blood-borne diseases.
Plasma donors and screening process
Donors themselves must undergo a comprehensive up front and ongoing review process. Prior to each donation, donors are assigned a unique ID, and registered in the Octapharma donor database. A deferral check is conducted, and a detailed health history is taken. An accredited healthcare professional then provides an overall assessment, and will exclude any donor that does not meet the acceptance criteria.
Once received from the collection centers, all donated plasma undergoes individual unit testing for antibodies against HIV-1/2, HBV, HCV and syphilis. Plasma also undergoes PCR (NAT) testing for HIV, HBV, HCV and parvovirus B19. The result of this process is an exceptionally pure, high quality fresh frozen plasma (FFP) product.
Plasma is prepared from whole blood donations or is directly obtained by automated plasmapheresis. It is free from detectable viruses, and contains specified levels of protective antibodies, coagulation factors and other important proteins. Plasma is rapidly frozen to preserve unstable proteins. It is maintained at -20°C or below during all storage and transport in a well controlled ‘cold chain’ system. Only plasma that meets all specified quality and safety criteria which also includes a 100% single donation control on site is released for production processes at Octapharma facilities.