ABSTRACT

The U.S. Food and Administration a certain number of foods, drugs, and medical devices that have been "nnnnlf·r1 for sterilization irradiation. For vaccines and other biological regulated by the Center for Evaluation and Research of the FDA radiation sterilization has been for

and diluent for vaccines. The in both cases is for sterilization cobalt-60 gamma radiation. Various studies the effects of radiation sterilization on biological products have been reported in the literature. Nedugova et a1. [1] listed the sterilizing effect of gamma radiation at doses of 20 for and 30 for solid preparations of cholera exotoxin. Terminal sterilization and viral

inactivation of blood products have been described by Reid [2]. Bazhanova et al. [3] reported the effects of radiation sterilization on the immunobiological properties of the sorbed protective fraction of Bordetella pertussis.