Laboratory studies were made to verify the capacity and efficacy of the pasteurisation step (heat treatment at 60 degrees C for 10 hours in stabilized aqueous solution) in inactivating various pathogenic viruses (e.g. HIV, HBV, HCV related viruses, HAV, HSV, poliovirus). These experiments proved that pasteurisation effectively inactivates a broad spectrum of viruses with a range of different physicochemical properties. The results, summarized in inactivation kinetics, demonstrate that complete inactivation of high quantities of both enveloped (e.g. HIV, HCV related viruses) and non-enveloped (e.g. poliovirus) viruses takes place during pasteurisation. In clinical trials on the virus safety of plasma derivatives no case of AIDS, hepatitis B or C occurred. From these data we conclude that heat treatment at 60 degrees C in a stabilized aqueous solution confers a high margin of safety on human plasma protein preparations regarding the transmission of diseases such as AIDS or hepatitis.
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