| 摘要 |
PURPOSE: A process for sterilization of biological compositions containing protein is provided, thereby retaining the integrity of the desired protein at a degree suitable for its purpose, and applying it to the inactivation of bacterial or viral preparations, when proteic components or proteic antigens are present, which are intended for use in inactivated or non-living vaccines. CONSTITUTION: The method for sterilizing a protein containing biological composition comprises the step of subjecting the composition to a virucidally effective amount of artificial irradiation in the presence of a substance of the formula (I), wherein R is H, CH3 or C2H5; at least one enveloped double-stranded DNA-virus and at least one non-enveloped single-stranded DNA-virus are inactivated by at least 4 Log; the irradiation is UV, IR, gamma-irradiation, x-ray or visible light; the irradiation is UVA, UVB or UVC; the irradiation is UVC at a wavelength of 240 to 290 nm, preferably 254 nm; the protein containing biological composition contains purified plasma proteins; the plasma protein is a coagulation factor; the coagulation factor is selected from the group consisting of factors V, VII, VIII, IX, X, XI and XIII and fibrinogen; the plasma protein retains at least 85% of its biological activity after treatment with irradiation; and not more than 5% of aggregates are formed during irradiation.
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