SÃO PAULO 2008 iii AGRADECIMENTOS Como forma de expressar minha gratidão pela ajuda e incentivo recebido na realização deste trabalho, desejo agradecer: Especialmente ao meu grande amigo Ricardo Shitsuka. Aos meus amigos que muito me ajudaram no laboratório de dosimetria do CTR-IPEN: Prof a. MsC. Célia M. Napolitano, Danilo C. Ferreira e Herman S. Zarate (o nosso amigo do Chile). Aos funcionários que me proporcionaram todo suporte e apoio necessários para operar na prática o irradiador

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... 220: Elizabeth S. R. Somessari ("Beth") e Carlos Gaia da Silveira ("Sr. Carlos"). Ao Prof. Dr. Fabio E. da Costa que sempre me forneceu sugestões importantes para este trabalho. Aos meus amigos do CMR -IPEN: Prof a . Dr a. Letícia Lucente Campos Rodrigues, pelo apoio na explicação sobre os dosímetros de CaSO 4 :Dy (TLD), Prof a . Dr a. Linda V. E. Caldas pelas orientações sobre dosimetria e Linda Theresse ao me ensinar a ler as doses absorvidas nos dosímetros CaSO 4 :Dy (TLD) no equipamento Harshaw. A todos os professores do IPEN pela dedicação e carinho com que lecionaram suas disciplinas. ABSTRACT The irradiation of human blood is used to avoid the TA-GVHD (transfusion-associated graft-versus-host-disease), a rare but devastating adverse effect of leukocytes present in blood components for a immunocompetent transfusion recipients. Usually this irradiation practice is performed to a physical elimination of leukocytes. The implementation of the procedures will assure that the properly dose in a range of 25 Gy to 50 Gy will be delivered to the blood in the bag collected in a blood tissue bank. The studies of the procedures in order to establish a GMP (Good Manufacturing Practices) were developed under the guidelines of the standard ISO 11137 -Sterilization of health care products -Requirements for validation and routine control -Radiation sterilization. In this work, two dosimetric systems were used for dose mapping during the studies of irradiator qualification, loading pattern, irradiation process validation and auditing. The CaSO 4 :Dy dosimeter presented difficulties concerning to uncertainty on dose measurement, stability, traceability and calibration. The PMMA and Gafchromic dosimetric systems have shown a better performance and were adopted on studies of irradiators qualification that are necessary to implementation of GMP. The irradiation tests have been done in a Gammacell 220 irradiator. The developed procedures can be adapted for different kinds of gamma irradiators, allowing implanting a quality assurance program and a GMP for blood irradiation. vi