Cleaning Validation: A Case Study Involving Dexamethasone Cream

In order to achieve a reliable degree of quality, the pharmaceutical industry needs to introduce a quality control system that includes validation of the cleaning of equipment. This study carried out cleaning validation on the dexamethasone cream production line. The validation study involved evalua...

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Detalles Bibliográficos
Autores principales: Freitas, Márcia R., Soares Sobrinho, José L., Granjeiro Júnior, Severino, Oliveira, Antônio D. P.
Formato: Articulo
Lenguaje:Inglés
Publicado: 2012
Materias:
Farmacia
cleaning validation; dexamethasone; quality control; semi-solids
Farmacología
Industria Farmacéutica
Control de Calidad
Dexametasona
Acceso en línea:http://sedici.unlp.edu.ar/handle/10915/18257
http://www.latamjpharm.org/resumenes/31/3/LAJOP_31_3_1_10.pdf
Aporte de:
SEDICI (UNLP) de Universidad Nacional de La Plata
id I19-R120-10915-18257
record_format dspace
institution Universidad Nacional de La Plata
institution_str I-19
repository_str R-120
collection SEDICI (UNLP)
language Inglés
topic Farmacia
cleaning validation; dexamethasone; quality control; semi-solids
Farmacología
Industria Farmacéutica
Control de Calidad
Dexametasona
spellingShingle Farmacia
cleaning validation; dexamethasone; quality control; semi-solids
Farmacología
Industria Farmacéutica
Control de Calidad
Dexametasona
Freitas, Márcia R.
Soares Sobrinho, José L.
Granjeiro Júnior, Severino
Oliveira, Antônio D. P.
Cleaning Validation: A Case Study Involving Dexamethasone Cream
topic_facet Farmacia
cleaning validation; dexamethasone; quality control; semi-solids
Farmacología
Industria Farmacéutica
Control de Calidad
Dexametasona
description In order to achieve a reliable degree of quality, the pharmaceutical industry needs to introduce a quality control system that includes validation of the cleaning of equipment. This study carried out cleaning validation on the dexamethasone cream production line. The validation study involved evaluation of the cleaning procedures for the dexamethasone cream production line. Samples were collected at thirteen points involving the reactor, the colloidal mill, the industrial blender, the mixer and the packaging machine, for each of the batches. Samples were collected for study of the residue of the principle active ingredient, of detergent, and for microbiological analysis. Cleaning was shown to be within the stipulated parameters (acceptable level = 9.95 μg/mL) for: residues of active ingredient, TOC, pH, conductivity and microbiological contamination. It was thus concluded that the strategy adopted for cleaning validation was simple, swift, and efficient and capable of being applied to other kinds of pharmaceutical products.
format Articulo
Articulo
author Freitas, Márcia R.
Soares Sobrinho, José L.
Granjeiro Júnior, Severino
Oliveira, Antônio D. P.
author_facet Freitas, Márcia R.
Soares Sobrinho, José L.
Granjeiro Júnior, Severino
Oliveira, Antônio D. P.
author_sort Freitas, Márcia R.
title Cleaning Validation: A Case Study Involving Dexamethasone Cream
title_short Cleaning Validation: A Case Study Involving Dexamethasone Cream
title_full Cleaning Validation: A Case Study Involving Dexamethasone Cream
title_fullStr Cleaning Validation: A Case Study Involving Dexamethasone Cream
title_full_unstemmed Cleaning Validation: A Case Study Involving Dexamethasone Cream
title_sort cleaning validation: a case study involving dexamethasone cream
publishDate 2012
url http://sedici.unlp.edu.ar/handle/10915/18257
http://www.latamjpharm.org/resumenes/31/3/LAJOP_31_3_1_10.pdf
work_keys_str_mv AT freitasmarciar cleaningvalidationacasestudyinvolvingdexamethasonecream
AT soaressobrinhojosel cleaningvalidationacasestudyinvolvingdexamethasonecream
AT granjeirojuniorseverino cleaningvalidationacasestudyinvolvingdexamethasonecream
AT oliveiraantoniodp cleaningvalidationacasestudyinvolvingdexamethasonecream
bdutipo_str Repositorios
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