A PROPOSAL OF PROCESS VALIDATION IN THE IMPLEMENTATION OF GOOD MANUFACTURING PRACTICES IN BRACHYTHERAPY SOURCES PRODUCTION

New laboratories for brachytherapy sources production are being implemented in our facility at IPEN, São Paulo. A great challenge implementing a laboratory is to comply with the Good Manufacturing Practices (GMPs), which involves process validation and all supporting activities such as cleaning sanitization. Much more than compliance regulatory guidelines, required certification inspections, builds large knowledge, provides possibilities optimization improvement, increasing degree of maturity people involved quality system. The results document that certifies any procedure, process, equipment, material, operation or system leads expected results. This work focused on new laboratory, been assembled produce small iodine-125 seeds. was performed three times evaluation. parameters evaluated this study were: source welding efficiency leakage tests (immersion test). doesn’t have an established parameter, since visually by operator, detection must be under 5 nCi / 185 Bq, accordingly ISO 9978. We observed values were average 79-87% nCi/seed. Although global aren’t available literature, showed high consistency acceptable percentages, especially when other similar manufacturing processes used comparison (average 85-70% found literature metallic structures). Those will important data drafting follow (GMPs).process