DRY HEAT VIRUS INACTIVATION UNDER CONTROLLED MOISTURE CONDITIONS

摘要

PROBLEM TO BE SOLVED: To provide a blood preparation not contg. viruses. SOLUTION: A freeze dried sample of a biologically active protein compsn. which puts the protein compsn. into the state of substantially not contg. the viruses and has a prescribed moisture content is prepd. The min. or threshold moisture content which will lead to a decrease of at least 3.2log10 in virus titre when the compsn. is heated up to low-temp. sterilization conditions is determined and thereafter, the sample is heated under the low-temp. sterilization conditions under which the decrease of at least 3.2log10 will be resulted while the biological activity of the protein is maintained.