Development of a process using electron beam for a terminal sterilization for parenteral formulations of pharmaceuticals
(2004) International Meeting on Radiation Processing — Location: Chicago(Il) (7.September.2003)
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- As pharmaceutical technology advances and sensitive drug formulations demand ever-greater stability, radiation processing is 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 using e-beam technology has been developed. A key feature of this process is the elucidation of defined conditions of radiation processing in order to achieve the homogeneity of the absorbed dose inside a single vial and throughout a tray containing several vials. Results of several dosimetry studies, using e-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 D-max/D-min across all dose-monitoring positions within the vial and throughout a tray containing 260 vials filled with a dry powder or a tray containing approximately 30 vials filled with an aqueous solution. This ionizing radiation process can be directly applicable, at a manufacturing level, for a terminal sterilization of parenteral formulations of pharmaceuticals. (C) 2004 Elsevier Ltd. All rights reserved.
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Citations
Matagne, D., Delbar, N., Hartmann, H., Gray, M., & Stickelmeyer, M. (2004). Development of a process using electron beam for a terminal sterilization for parenteral formulations of pharmaceuticals. Radiation Physics and Chemistry, 71(1-2), 421-424. https://doi.org/10.1016/j.radphyschem.2004.03.041 (Original work published 2004)