Thesis REDUCCIÓN DE SCRAP EN LÍNEA DE PRODUCCIÓN DE MEDICAMENTOS PARENTERALES ENVASADOS EN AMPOLLAS DE VIDRIO EN FRESENIUS KABI CHILE
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Date
2021
Authors
RUBIO MONTALVA, IGNACIO ALEJANDRO
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Abstract
La presente memoria de tesis se centró en la reducción de scrap en el proceso productivo de medicamentos parenterales envasados en ampollas de vidrio en la Planta Vidrio de la empresa Fresenius Kabi Chile. Scrap se define como todo desecho y/o desperdicio derivado del proceso industrial. Esto se llevó a cabo utilizando la metodología DMAIC (definir, medir, analizar, mejorar y controlar) que consiste en una herramienta Six Sigma, método utilizado para reducir la variabilidad de los procesos productivos que derivan en defectos de calidad. En primer lugar, se describió el proceso productivo llevado a cabo en Planta Vidrio para los medicamentos envasados en ampollas de vidrio. Usando la metodología DMAIC, primero se definió el objetivo del proyecto de mejora, que sería la disminución del scrap en el proceso productivo llevado a cabo en la máquina de Línea Compacta y en las máquinas Rotas 463-465 y Rotas 464-466. Para distinguir en qué etapas de todo el proceso productivo se producía el mayor scrap, se realizó un mapeo de procesos a nivel detallado para todas las etapas del proceso de fabricación, siendo estos los siguientes: despacho de ampollas, movimiento de pallets entre bodegas, lavado y traspaso de ampollas, envase, revisión y empaque. Con el mapeo se encontró que el proceso que mayor porcentaje de scrap generaba era el proceso de envase, por lo que se tomó la información recopilada durante los mapeos a este proceso y se construyó un diagrama de Ishikawa donde se listaron las causas raíces que generaban el scrap en el proceso de envase. De este análisis se obtuvo que una de las pérdidas más significativas del proceso era un sobrante de solución inyectable que se identificaba al final del lote, contenido en el estanque utilizado en el proceso. Para minimizar la pérdida de solución sobrante, se decidió aplicar una mejora en respecto a la cantidad de ampollas vacías que ingresaban al proceso de envase, aumentando las unidades por lote con el fin de envasar la mayor cantidad de solución posible. Se implementó la mejora en los lotes envasados entre enero y octubre del año 2021 para las máquinas Rotas 463-465 y Rotas 464-466 y entre abril y octubre del año 2021 para Línea Compacta. El 75% de los lotes envasados en las primeras 2 máquinas correspondieron a lotes con la mejora, mientras que, para la otra máquina, el 38% de los lotes envasados en el período correspondieron a los que tenían la mejora.
The following thesis report was centered on the scrap reduction of the productive process of parenteral medication contained in glass ampoules on the glass plant of Fresenius Kabi Chile. Scrap is defined as any waste or garbage derived from the industrial process. This project was carried out using DMAIC (define, measure, analyze, improve, control) methodology which consists in a Six Sigma tool, method used to reduce variability in productive processes, which lead to quality defects. Firstly, the production process of medication contained in glass ampoules, carried out at glass plant was described. Using DMAIC methodology, the first thing was to define the project objective, which was the scrap reduction in the productive process carried out in Compact Line machine and Rotas 463-465 and Rotas 464-466 machines. In order to specify in which part of the entire process the most scrap was produced, a detailed process mapping was carried out for all the processes involved, which were: glass ampoules dispatch, pallet movement between warehouses, washing and transfer of glass ampoules, filling process, revision process and packing. With the process mapping, it was found that the most scrap was generated in the filling process, so the compiled information from this process was taken and an Ishikawa diagram was built and the root causes that generated the scrap in the filling process were listed. From this analysis, it was found that there was always a solution leftover at the end of every batch that was contained in the tank used for the process. To minimize the solution scrap, it was decided that an improvement to the number of empty glass ampoules that entered the filling process should be performed, to fill a greater amount of glass ampoules. The improvement was performed for batches filled between January and October of 2021 for Rotas 463-465 and Rotas 464-466 machines and between April and October of 2021 for batches filled in Compact Line. 75% of batches produced during this period for the first 2 machines had the improvement, whilst 38% of batches produced in Compact Line had the improvement.
The following thesis report was centered on the scrap reduction of the productive process of parenteral medication contained in glass ampoules on the glass plant of Fresenius Kabi Chile. Scrap is defined as any waste or garbage derived from the industrial process. This project was carried out using DMAIC (define, measure, analyze, improve, control) methodology which consists in a Six Sigma tool, method used to reduce variability in productive processes, which lead to quality defects. Firstly, the production process of medication contained in glass ampoules, carried out at glass plant was described. Using DMAIC methodology, the first thing was to define the project objective, which was the scrap reduction in the productive process carried out in Compact Line machine and Rotas 463-465 and Rotas 464-466 machines. In order to specify in which part of the entire process the most scrap was produced, a detailed process mapping was carried out for all the processes involved, which were: glass ampoules dispatch, pallet movement between warehouses, washing and transfer of glass ampoules, filling process, revision process and packing. With the process mapping, it was found that the most scrap was generated in the filling process, so the compiled information from this process was taken and an Ishikawa diagram was built and the root causes that generated the scrap in the filling process were listed. From this analysis, it was found that there was always a solution leftover at the end of every batch that was contained in the tank used for the process. To minimize the solution scrap, it was decided that an improvement to the number of empty glass ampoules that entered the filling process should be performed, to fill a greater amount of glass ampoules. The improvement was performed for batches filled between January and October of 2021 for Rotas 463-465 and Rotas 464-466 machines and between April and October of 2021 for batches filled in Compact Line. 75% of batches produced during this period for the first 2 machines had the improvement, whilst 38% of batches produced in Compact Line had the improvement.
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Keywords
MEDICAMENTOS , DESECHOS INDUSTRIALES , INDUSTRIA FARMACEUTICA