Determination of the worst case for cleaning validation of equipment used in the radiopharmaceutical production of lyophilized reagents for sup(99)Tc labeling
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Brazilian Journal of Pharmaceutical Sciences
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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
Energéticas e Nucleares (IPEN-CNEN/São 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.
Como referenciar
PORTO, LUCIANA V.F.M.; FUKUMORI, NEUZA T.O.; MATSUDA, MARGARETH M.N. Determination of the worst case for cleaning validation of equipment used in the radiopharmaceutical production of lyophilized reagents for sup(99)Tc labeling. Brazilian Journal of Pharmaceutical Sciences, v. 52, n. 1, p. 105-112, 2016. DOI: 10.1590/S1984-82502016000100012. Disponível em: http://repositorio.ipen.br/handle/123456789/26857. Acesso em: 30 Dec 2025.
Esta referência é gerada automaticamente de acordo com as normas do estilo IPEN/SP (ABNT NBR 6023) e recomenda-se uma verificação final e ajustes caso necessário.