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KMID : 0357520100330040387
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Journal of Radiological Science and Technology
2010 Volume.33 No. 4 p.387 ~ p.394
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The Research Relating to QA of the Absorbed Dose in the 10 MeV E-beam Facility in Accordance with the International Standards
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Ha Tae-Sung
Ahn Cheol
Jung Pyeong-Hwan
Cho Jung-Heui
Lee Jong-Suk
Lee Hye-Nam
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Abstract
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In the field of healthcare, the conventional sterilization treatments have been replaced by irradiation methods which are in accordance with internationally well established quality standards. The quality control in radiation sterilization assures that the absorbed dose of the irradiated material is in agreement with its requirements and standards. The electron beam irradiation requires technical assessments of more process parameters than gamma irradiation does. Korea has witnessed wide uses of electron accelerators since early 2000 but there hasn’t been research experiences relating to quality system in accordance with international standards. The new large scale e-beam irradiation system with the specification of 10 MeV, 8 kW was installed and operated in 2008 by Seoul Radiology Services Co. It consists of the electron accelerator, product handling system, safety, documentation and control subsystems into an integrated system to meet the requirement of the Good Manufacturing Practice such as process quality assurance and management of product tracking records. To implement the international standard such as EN ISO11137, it is necessary to understand the purposes aimed in the standard and carry out the tests following the procedures required. This study presented the specification of the e-beam facility and showed what its design requirements and features are. The test results on a variety of process parameters were presented and validated it they are within the required limits.
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KEYWORD
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Radiation Sterilization, Quality Assurance, Absorbed Dose, Electron Beam, Dosimetry
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