Abstract
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.
Highlights
Mestre em Engenharia de Materiais – USP; Coordenador dos cursos de Tecnologia em Redes e TI – FACSP
Two dosimetric systems were used for dose mapping during the studies of irradiator qualification, loading pattern, irradiation process validation and auditing
E668 – 97 standard was used that establishes the the requirements for validation and routine conuse of termoluminescent dosimeters (TLDs) to trol, using the ionizing radiation for sterilization estimate the absorbed dose in processed materiof products for health providing with details and als by ionizing radiation
Summary
IPEN is appropriate to be used in the routine blood irradiation, because the safe design and operation has make it a good choice for high dose rate radiation studies. The dosimetric system TLD revealed to be inappropriate for utilization in blood irradiators dosimetry, due to the lack of response uniformity. The PMMA and Gafphcromic dosimeters had revealed to be adequate for dosim-. The TLDs readings of the doses were very etry in irradiations of blood components, assuring dispersed, complicating the accomplishment of that the Gammacell 220 irradiator can be used in the calibration tests and the dose mapping of the the blood irradiation.
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