Resumo

GONZALEZ FERNANDEZ, Ángel L. et al. Technological and engineering solutions in the radiopharmaceuticals production. Nucleus [online]. 2012, n.52, pp. 13-19. ISSN 0864-084X.

The paper discusses the conception and original design of the Isotope Centre’s facilities, and structural changes made to the centre over 15 years of operation with the aim of meeting the Good Manufacturing Practices Regulations nonexistent at the time of its commissioning. Particular emphasis is given to the changes made to hot cells, glove boxes, and also some aspects related to technological processes. As a result, the CENTIS productions fulfil international standards and its facilities have been validated in correspondence with the national regulations. Steps are directed not only to meet the requirements of ISO 9000 and GMP, but to ensure optimization and flexibility in the use of the facilities.

Palavras-chave : hot cells; gloveboxes; ventilation systems; ionization chambers; radiopharmaceuticals; quality assurance.

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