Determination of the worst case for cleaning validation of equipment used in the radiopharmaceutical production of lyophilized reagents for sup(99)Tc labeling

dc.creatorPORTO, LUCIANA V.F.M.
dc.creatorFUKUMORI, NEUZA T.O.
dc.creatorMATSUDA, MARGARETH M.N.
dc.date2016
dc.date2016-12-02T19:44:29Z
dc.date2016-12-02T19:44:29Z
dc.date.accessioned2023-09-28T13:31:39Z
dc.date.available2023-09-28T13:31:39Z
dc.identifier1984-8250
dc.identifierhttp://repositorio.ipen.br/handle/123456789/26857
dc.identifier1
dc.identifier52
dc.identifier10.1590/S1984-82502016000100012
dc.identifier3.696
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8997149
dc.descriptionCleaning 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.
dc.format105-112
dc.relationBrazilian Journal of Pharmaceutical Sciences
dc.rightsopenAccess
dc.subjectcleaning
dc.subjectvalidation
dc.subjectequipment
dc.subjectradiopharmaceuticals
dc.subjectproduction
dc.subjectlyophilization
dc.subjectreagents
dc.subjecttechnetium isotopes
dc.subjectlabelling
dc.subjectdrugs
dc.subjectfabrication
dc.titleDetermination of the worst case for cleaning validation of equipment used in the radiopharmaceutical production of lyophilized reagents for sup(99)Tc labeling
dc.typeArtigo de peri??dico
dc.coverageI


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