Good manufacturing practices (gmp) utilized on human blood irradiation process DOI: 10.5585/exacta.v6i1.800

• Published in: Exacta Vol. 6; no. 1; pp. 35 - 40
• Main Authors: Boghi, Cláudio, Shitsuka, Dorlivete Moreira, Alexandruk, Marcos, Shitsuka, Ricardo, Rela, Paulo Roberto
• Format: Journal Article
• Language: English
• Published: 10.02.2009
• ISSN: 1678-5428; 1983-9308
• DOI: 10.5585/exactaep.v6i1.800

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 immunocompetent transfusion recipients. Usually this irradiation practice is performed to a physical elimination of lymphocytes. The implementation of the GMP will assure that the properly dose in a range of 25Gy to 50Gy will be delivered to the blood in the bag collected in a blood tissue bank. The studies to establish the GMP 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 CaSO4: Dy dosimeter presented difficulties concerning to uncertainty on dose measurement, stability, trace ability and calibration system. The PMMA and gafchromic dosimetric systems have shown a better performance and were adopted on establishment of GMP procedures. The irradiation tests have been done using a Gammacell 220 Irradiator. The developed GMP can be adapted for different types of gamma irradiators, allowing to set up a quality assurance program for blood irradiation.