When medicinal products prepared from human blood or plasma are administered, infectious diseases due to the transmission of infective agents cannot be totally excluded. This applies also to pathogens of hitherto unknown nature.
To reduce the risk of transmission of infective agents, donors and donations are duly screened.
Each unit of plasma used for the preparation of Human Albumin was tested and found negative for the presence of HBsAg, of HIV 1, HIV 2 and HCV antibodies, and was tested for the ALT content; the plasma pool has also been controlled for the presence of HCV-RNA through a genic amplification technique and the result was non reactive. The production process includes procedures for the removal and inactivation of viruses.
The ultrafiltration and diafiltration treatment removes metal ions; the risk of aluminum accumulation and of the toxicity related thereto are therefore drastically reduced.