The main steps on implementation of radiation processing technology - portuguese experience

The development of applications of ionizing radiation for Industrial purposes in Portugal began near of 1982 with the support of IAEA under the program of Cooperation and Technical Assistance - project POR/8/002. The IAEA program of Cooperation and Technical Assistance permitted that POR/08/002 took place between 1983 up to 1988. The collaboration of the International Experts and the personnel of National Laboratory of Industrial Engineering and Technology, nowadays Nuclear and Technologic Institute (ITN), allowed the construction of a Co-60 irradiation plant, designed by Tecnabexport (Russia). This facility is located in the ITN campus in Sacavem, Portugal. The main parameters studied prior to the implementation (sitting, design, construction, commissioning, operation, maintenance and foreseen decommission) were planned and executed according with the Portuguese legislation which is based on the International rules (IAEA Safety series) and Directive EURATOM 836/80, nowadays EURATOM 1493/93. A study of the geological stability of the site for future placement of the irradiation facility was done preceding the construction. The facility was constructed under Portuguese responsibility but designed and loaded with Co-60 by the Russian business rganization: Technabexport between 1987 and 1988. The whole process was supervised and approved by the ITN's Nuclear Protection and Safety Department. The Cobalt-60 irradiation facility was initially named GammaPi and later on Radiation Technologies Unit (UTR) and its management was under ITN's authority until 2003. Once established a quality system for the gamma facility, the following phase is to develop, validate and control the sterilization/disinfection process. In this step, a multidisciplinary approach and a continuous dialog with product managers and personnel must be taken into consideration in the experimental design for the correct and effective establishment of irradiation process. The knowledge of product's elements (raw material, personnel and equipment) and line production stages are important factors to the safety and quality of the irradiated product. The research activities carried on in the UTR have been closely related with the main applications of his technology namely, the sterilization of medical devices and pharmaceuticals and other products' decontamination. These activities have frequently been followed through by industries. These circumstances have lead to an increase interest of the industrial sector to gamma radiation sterilization processes.