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Previous issue date: 2014-10-27 / Coordena??o de Aperfei?oamento de Pessoal de N?vel Superior - CAPES / O controle estat?stico de processos ? uma estrat?gia que tem sido cada
vez mais utilizada para o monitoramento on-line de processos industrias, no
qual a principal ferramenta utilizada s?o as cartas de controle, que podem ser
univariadas ou multivariadas, de acordo com o n?mero de vari?veis envolvidas
no monitoramento. Basicamente, as cartas de controle s?o gr?ficos estat?sticos
que possuem uma faixa de toler?ncia limitada pelas linhas superior e inferior,
calculadas com base no desvio padr?o das amostras em condi??es de
controle. Este trabalho apresenta a aplica??o de cartas de controle
multivariadas baseadas em duas filosofias: no vetor NAS (do ingl?s, Net
Analyte Signal) e na an?lise de componentes principais (do ingl?s, Principal
Component Analysis- PCA), utilizando a espectroscopia no infravermelho
pr?ximo (NIR, do ingl?s, Near Infrared) no monitoramento simult?neo de teor
de dois f?rmacos, isoniazida e rifampicina, em formula??es farmac?uticas
produzidas pelo NUPLAM (N?cleo de Pesquisa em Alimentos e Medicamentos)
da UFRN. As cartas foram constru?das utilizando amostras provenientes de um
planejamento experimental e da linha de produ??o do NUPLAM. As cartas de
controle via escores de PCA para o monitoramento simult?neo dos dois APIs
apresentaram taxas de acerto acima de 92% na classifica??o das amostras de
calibra??o e valida??o, e 100% de acerto na previs?o. As cartas via NAS para
isoniazida obtiveram 100% de acerto na classifica??o das amostras da
calibra??o e previs?o. As cartas NAS para rifampicina obtiveram taxas de
acerto acima de 90,0% na calibra??o e previs?o. A partir dos resultados
obtidos, evidencia-se a aplicabilidade das cartas de controle multivariadas para
o controle de processos de uma ind?stria farmac?utica, diminuindo custo e
tempo de an?lise, gerando menos res?duos e consequentemente, otimizando o
processo de controle de qualidade. / Statistical process control is a strategy that has been increasingly used
for online monitoring of industrial processes. It is the main tool used for control
charts, which can be univariate or multivariate, according to the number of
variables involved in monitoring. Basically, control charts are statistical graphs
that have a tolerance range bounded by upper and lower lines, calculated
based on the standard deviation of the samples in control conditions. This paper
presents the application of multivariate control charts based on two
philosophies: the NAS (Net Analyte Signal) vector and the principal component
analysis (Principal Component Analysis - PCA), using Near Infrared
Spectroscopy for the simultaneous monitoring of level two drugs; isoniazid and
rifampicin in pharmaceutical formulations produced by NUPLAM (Center for
Research on Food and Drug Administration) at UFRN. The charts were
constructed using samples from an experimental design and the NUPLAM
production line. Control Charts via PCA scores for the simultaneous monitoring
of both APIs showed accuracy rates above 92% in the classification of samples
for calibration and validation, and 100% accuracy in prediction. The charts via
NAS to isoniazid had 100% accuracy in classifying samples of calibration and
prediction. The NAS charts to rifampicin achieved hit rates above 90.0% in the
calibration and prediction. The results obtained demonstrate the applicability of
multivariate control charts for the control of pharmaceutical processes, thereby
reducing cost and time of analysis, generating less waste and thus optimizing
the quality control process.
| Identifer | oai:union.ndltd.org:IBICT/oai:repositorio.ufrn.br:123456789/19673 |
| Date | 27 October 2014 |
| Creators | Costa, Fernanda Saadna Lopes da |
| Contributors | 03144855464, Bicudo, Tatiana de Campos, 25935096862, Silva J?nior, Arn?bio Antonio da, 00840406452, Ferr?, Roma Tauler, 00000000000, Rocha, Werickson Fortunato de Carvalho, 05394736693, Lima, K?ssio Michell Gomes de |
| Publisher | Universidade Federal do Rio Grande do Norte, PROGRAMA DE P?S-GRADUA??O EM QU?MICA, UFRN, Brasil |
| Source Sets | IBICT Brazilian ETDs |
| Language | Portuguese |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, info:eu-repo/semantics/masterThesis |
| Source | reponame:Repositório Institucional da UFRN, instname:Universidade Federal do Rio Grande do Norte, instacron:UFRN |
| Rights | info:eu-repo/semantics/openAccess |
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