期刊Development of a process using electron beam for a terminal sterilization for parenteral formulations of pharmaceuticals.pdfVIP

ARTICLE IN PRESS Radiation Physics and Chemistry 71 (2004) 419–422 Development of a process usin gelectron beam for a terminal sterilization for parenteral formulations of pharmaceuticals a, a b c c D. Matagne *, N. Delbar , H.-J. Hartmann , M. Gray , M. Stickelmeyer a Eli Lilly and Company, Lilly Development Centre, B-1348 Mont-Saint-Guibert, Belgium b Studer AG Werk Hard, CH-4568 Da iken, Switzerland ¨n c Eli Lilly and Company, Lilly Research Laboratories, Indianapolis, IN 46285, USA Abstract As pharmaceutical technology advances and sensitive dru gformulations demand ever-greater stability, radiation processin gis likely the only alternative that can be used to terminally sterilize thermo-labile pharmaceutical products intended for parenteral administration. To this end, a radiation process usin ge-beam technology has been developed. A key feature of this process is the elucidation of defined conditions of radiation processin gin order to achieve the homogeneity of the absorbed dose inside a single vial and throughout a tray containin gseveral vials. Results of several dosimetry studies, usin ge-beam technology, demonstrate the beneficial effects of the use of aluminum or stainless-steel plates to scatter the beam and therefore to obtain an excellent Dmax =Dmin across all dose- monitorin gpositions within the vial and throughout a tray containin g260 vials filled with a dry powder or a tray