期刊A new e-beam application in the pharmaceutical industry.pdfVIP

Nuclear Instruments and Methods in Physics Research B 240 (2005) 100–104 /locate/nimb A new e-beam application in the pharmaceutical industry Theo Sadat, Fiona Malcolm * LINAC Technologies, 16, rue Nicolas Appert, 91400 Orsay, France Available online 9 August 200 Abstract The paper presents a new electron beam application in the pharmaceutical industry: an in-line self-shielded atropic transfer system using electron beam for surface decontamination of products entering a pharmaceutical filling line. The unit was developed by Linac Technologies in response to the specifications of a multi-national pharmaceutical com- pany, to solve the risk of microbial contamination entering a filling line housed inside an isolator. In order to fit the sterilization unit inside the pharmaceutical plant, a ‘‘miniature’’ low-energy (200 keV) electron beam accelerator and e-beam tunnel were designed, all conforming to the pharmaceutical good manufacturing practice (GMP) regulations. Process validation using biological indicators is described, with reference to the regulations govern- ing the pharmaceutical industry. Other industrial applications of a small-sized self-shielded electron beam sterilization unit are mentioned. 2005 Elsevier B.V. All rights reserved. PACS 81.40.Wx Keywords Sterilization; e-Beam; Electron beam; Low-energy beam; Irradiation; e-Beam tunnel 1. Introduction Other methods of product decontamination prior to insertion in a sterile area are hydrogen peroxide, A continuous surface treatment system using pulsed light, double or triple outer bag. The