Radiation sterilization as safe and effective way to obtain sterile biapenem.

Biapenem is parenteral carbapenem antibiotic with a broad spectrum of activity. The objective of the study was to confirm that β -radiation irradiation with electron beam with a delivered dose of 25 kGy allows to obtain a sterile biapen, characterized by unchanged physicochemical and microbiological properties. Biological and chemical changes of biapenem were only observed when 400 kGy was used (the dose 16 times higher than dose needed to sterilization). The degradation product from radiolysis was identified by the LC-MS/MS method. Radiosterilization Radiation sterilization is safe and effective method of biapenem sterilization. • Radiosterilization is a safe and effective method for obtaining sterile biapenem. • The safety of radiosterilization was studied by FT-IR, Raman, XRPD techniques. • The effectiveness of biapenem radiosterilization was confirmed by microbiological tests. [ABSTRACT FROM AUTHOR]