History
 

FABAD  J. Pharm. Sci.
ISSN 1300-4182
Copyright Ó 2008 FABAD. All rights reserved 

FABAD J. Pharm. Sci., 33(4), 205-209, 2008. PDF (388 KB)

Scientific Review

ABSTRACT

Radiopharmaceuticals Industry Based On the Brazilian Regulations
Ralph SANTOS-OLIVEIRA*, Clayton Augusto BENEVIDES**, Emilia Rahnemay KOHLMAN-RABBANI***, Ione Maria Acioly RICARTE-FREITAS****
* Nuclear Engineering Institute, Rua Hélio de Almeida n.75 , Cidade Universitária, Rio de Janeiro-RJ, Brazil.
** Brazilian Nuclear Energy Commission. Av. Prof. Luiz Freire, 200, Recife-PE, Brazil.
*** State University of Pernambuco. Master´s Program in Civil Engnineering. Occupational Safety and Health Laboratory. Rua Benfica, 455 Bloco I Sala 01, Madalena, Recife-PE, Brazil.
**** Northeast Centre of Nuclear Science, State University of Pernambuco. Av. Prof. Luiz Freire, 200, Recife-PE, Brazil.


Summary


The present work is concerned with all requirements recommended by the Brazilian Good Manufacturing Practices for Pharmaceuticals and Occupational Safety and Health Regulations required for Health Services. Due the fact that Brazilian regulations are not specific to radiopharmaceutical production, the facility presented in this work will provide a national standard in this area. This facility is intended to produce radiopharmaceuticals completely capable of being certified under the most rigorous worldwide standards. The most important aspects and requirements of air quality control, radiation protection, cleaning rooms, personnel and Quality Assurance are covered in this work to create a prototype of an installation that is capable of producing radiopharmaceuticals for use in state-of-art diagnostic procedures.

Key Words :
Civil engineering, radiopharmaceutical industry, layout, design, PET radiopharmaceuticals.