Radiation sterilization of antibiotic liposome formulations:A case study

摘要

New liposome formulations for antimycobacterial purpose are under development in Portugal.The drug must be submitted to a sterilization process.In order to find out if gamma radiation could be applied,microbiological and chemical studies were developed based on ISO standards.The bioburden was determined,the main critical points of line production were detected and the sterilization dose was determined based on a chart control for bioburden.A preliminary maximum acceptable dose for product was found out based on the main functional parameters.