A priority in every link of the chain

Voluntary non-remunerated donors
NBI's products are prepared from pooled human plasma sourced predominantly from non-remunerated healthy blood donors. Blood donors in South Africa are those people who voluntarily donate their blood or components to be used in accordance with the Human Tissue Act (Act 65 of 1983).

Donor screening
A range of questions on a confidential questionnaire determines the prospective donor's medical condition, health and any high-risk behaviour patterns. The donor is permanently deferred or deferred for a period of time depending on the answers to the questions.

Individual donation testing
All units of blood are individually tested and found non-reactive for hepatitis B surface antigen (HBsAg), antibodies to the hepatitis C virus, antibodies to the human immunodeficiency viruses, HIV-1 and HIV-2.

Approved plasma suppliers
The acquisition of plasma is predominantly from the South African National Blood Services (SANBS) and other internationally regulated suppliers.

Pooling of individual plasma units
Processes such as cold ethanol fractionation, have been introduced to enhance product safety, quality and efficacy.

Internationally accepted viral inactivation/reduction processes
The methods of manufacture include effective processes such as solvent-detergent treatment, pH 4 treatment and pasteurisation, which have been shown to inactivate the important transfusion transmitted lipid enveloped viruses, including the human immunodeficiency viruses (HIV-1 and HIV-2), hepatitis B and hepatitis C viruses.

Quality assurance for final product release
NBI plasma products fulfil the registration requirements of the South African regulatory authority, the Medicines Control Council, in terms of safety, quality and efficacy.