Method for reducing or inactivating viral and microbial content in the processes for the manufacture of pancreatin

摘要

A method for the reduction or inactivation of viral and microbial content in the manufacturing of pancreatin API is disclosed. The method includes treating animal-derived tissue with peracetic acid to reduce viral activity and bacterial load prior to processing. In particular, the method includes treating porcine pancreas glands with peracteic acid prior to extracting a pancreatin API from the treated glandular tissue.