Challenges in iodine-125 sources production for cancer treatment
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2023
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INTERNATIONAL SYMPOSIUM ON TRENDS IN RADIOPHARMACEUTICALS
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Resumo
There is a great challenge the implantation on assurance quality system in the brachytherapy
sources production. It involves tofulfill the Good Manufacturing Practices (GMPs) requirements,
involving the process validation and of all supporting activities such as cleaning and sanitization.
The purpose of this work was to execute a process validation in the iodine-125 seeds production
on Radiation Technology Center located at IPEN- Brazil. Besides this, the sanitization was to
evaluate the effectiveness of different surface cleaning products, determining the best to reduce
radiological contamination to acceptable levels during the sources production, according to
legislation. The fabrication process was performed three times for evaluation. The parameters
evaluated in this study were: the source welding efficiency and the leakage tests results (immersion
test). The welding efficiency doesn’t have an established parameter, since is visually evaluated by
the operator, and the leakage detection has to be under 5 nCi / 185 Bq, accordingly with the ISO
9978. In the relation of sanitization, it was established a cleaning program for three production lots
of iodine 125 seeds using three types of sanitizers: Lot 1 with extran 1/1 (v/v), Lot 2 with hydrogen
peroxide 6% and Lot 3 with sodium hydroxide 1M. Each lots contained seven iodine 125 seeds
and was immersed in the sanitizer for 1 hour and then two washes with distilled water. An activity
detected in each lots does not exceed 0,2 kBq (˭5nCi). The observed values on process validation
were: 75% welding efficiency and 32% leakage detection. Although established values for the
global efficiency aren’t available in the literature, the results showed high consistency and
acceptable percentages, especially when other similar manufacturing processes are used in
comparison (average 85-70% found in the literature for other similar metallic structures).
According to results of sanitization, the best choice for remove de surface contamination was
peroxide hydrogen. Further testing should ensure the sanitizer's choice is based not only on the
removal of surface contamination, but also this sanitizer does not leave residues requiring further
rinsing with distilled water. Those values will be important data when drafting the validation
document and to follow the Good Manufacturing Practices (GMPs).
Como referenciar
FEHER, ANSELMO; BAPTISTA, TATYANA S.; ZEITUNI, CARLOS A.; ROSTELATO, MARIA E.C.M.; MOURA, JOÃO A. Challenges in iodine-125 sources production for cancer treatment. In: INTERNATIONAL SYMPOSIUM ON TRENDS IN RADIOPHARMACEUTICALS, April 17-21, 2023, Vienna, Austria. Abstract... Vienna, Austria: International Atomic Energy Agency - IAEA, 2023. p. 25-25. Disponível em: http://repositorio.ipen.br/handle/123456789/34539. Acesso em: 13 Mar 2025.
Esta referência é gerada automaticamente de acordo com as normas do estilo IPEN/SP (ABNT NBR 6023) e recomenda-se uma verificação final e ajustes caso necessário.