Artigo de peri??dico
Determination of the worst case for cleaning validation of equipment used in the radiopharmaceutical production of lyophilized reagents for sup(99)Tc labeling
Registro en:
1984-8250
1
52
10.1590/S1984-82502016000100012
3.696
Autor
PORTO, LUCIANA V.F.M.
FUKUMORI, NEUZA T.O.
MATSUDA, MARGARETH M.N.
Resumen
Cleaning validation, a requirement of the current Good Manufacturing Practices (cGMP) for Drugs,
consists of documented evidence that cleaning procedures are capable of removing residues to
predetermined acceptance levels. This report describes a strategy for the selection of the worst case product
for the production of lyophilized reagents (LRs) for labeling with 99mTc from the Instituto de Pesquisas
Energ??ticas e Nucleares (IPEN-CNEN/S??o Paulo). The strategy is based on the calculation of a ???worst
case index??? that incorporates information about drug solubility, cleaning difficulty, and occupancy rate in
the production line. It allowed a reduction in the required number of validations considering the possible
manufacturing flow of a given product and the subsequent flow, thus facilitating the process by reducing
operation time and cost. The products identified as ???worst case??? were LRs PUL-TEC and MIBI-TEC.