1. Soluciones tecnológicas e ingenieriles en la producción de radiofármacos.
- Author
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L. González Fernández, Ángel, Falcón Pérez, Lázaro, Dimas Díaz Jilímas, Eduardo, Sánchez Anaya, Eduardo, Maqueira Morales, Juan, Fernández Quintero, Gerardo, and Suárez Beyries, Karina
- Subjects
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RADIOPHARMACEUTICALS , *RADIOISOTOPES , *MANUFACTURING processes , *MATHEMATICAL optimization , *IONIZATION chambers , *GLOVE boxes (Safety devices) , *QUALITY assurance - Abstract
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 fulfi l 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 fl exibility in the use of the facilities [ABSTRACT FROM AUTHOR]
- Published
- 2012