The focus of chemical manufacturing and control evaluation of 60Co gamma-sterilization on chemical drugs
60Co-γ radiation is considered as one representative ionizing radiation used in sterilization.With advantages such as high-level penetration and cold treatment,it has attracted increasing attention in the area of chemical drugs.In this article,we summarized domestic and global regulatory requirements,as well as our review practices.Furthermore,we discussed the main concerns of gamma-sterilization utilized in chemical medicines from different perspectives,including degradation of active substances or carrier materials,radiolysis products,packaging material compatibility and sterilization process validation.We expect that this article will provide some reference for the application of 60Co-γ radiation in chemical drug sterilization.
sterilization by radiationradiation doseradiolysis productschemical manufacturing and control evaluation
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