Validación del proceso de llenado aséptico de inyectables de pequeño volumen de un Laboratorio Farmacéutico Nacional
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Date
2021
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Universidad Nacional de Trujillo
Abstract
El presente estudio tuvo como objetivo validar el proceso del llenado aséptico en la Línea N° 3 de la sección de Pequeño Volumen 1 (PV1) de un Laboratorio Farmacéutico Nacional, que comprende las conexiones asépticas para la filtración de soluciones y las operaciones asépticas en el proceso de envasado en ampollas de vidrio incoloro de 5mL ,utilizando la envasadora y selladora de ampollas Truking empleando solución de Caldo Digerido de Caseína y Soya y solución de Tioglicolato en lugar de producto. Antes de realizar el proceso de llenado aséptico se tuvo en cuenta las diferentes variables del proceso para establecer las condiciones de peor caso, como: la velocidad de la máquina envasadora, la complejidad de las operaciones, el sistema de envase primario, entre otros. En la operación de filtración se utilizó un filtro cápsula de 0,2 µm y un recipiente de vidrio para la recepción de la solución de medio de cultivo filtrado. Durante el proceso de envasado se realizaron las intervenciones rutinarias como el montaje del sistema de envase, la conexión y desconexión del sistema de envase y la regulación de la dosificación. Se realizaron pruebas como: unidades contaminadas, esterilidad en muestra del granel, obteniendo resultados estériles. En la prueba de promoción de crecimiento se obtuvo resultados conformes en los tres lotes de medio de cultivo En la prueba de monitoreo ambiental del aire se encontró resultados <1 ufc/placa. En el monitoreo de superficies y de uniformes del personal se obtuvo resultados <1ufc/placa. Las ampollas envasadas se incubaron durante 14 días a dos temperaturas: 7 días de 20 °C a 25 °C y 7 días de 30 °C a 35 °C. Al término de los 14 días fue examinado el contenido de las ampollas para detectar cualquier contaminación. Finalmente, se validó el proceso de llenado aséptico de inyectables de pequeño volumen, cumpliendo con los criterios de aceptación.
ABSTRACT The objective of this study was to validate the aseptic filling process in Line N°3 of the Small Volume 1 (PV1) section of a National Pharmaceutical Laboratory, which includes aseptic connections for the filtration of solutions and aseptic operations in the process of packaging in 5mL colorless glass ampoules, using the Truking ampoule sealer and sealer using Digested Casein and Soy Broth solution and Thioglycollate solution instead of product. Before carrying out the aseptic filling process, the different variables of the process were taken into account to establish the worst-case conditions, such as: the speed of the packaging machine, the complexity of the operations, the primary packaging system, among others. In the filtration operation, a 0.2 µm capsule filter and a glass container were used to receive the filtered culture medium solution. During the packaging process, routine interventions such as the assembly of the packaging system, the connection and disconnection of the packaging system and the regulation of the dosage were carried out. Tests were carried out such as: contaminated units, sterility in bulk sample, obtaining sterile results. In the growth promotion test, consistent results were obtained in the three batches of culture medium. In the air environmental monitoring test, results <1 cfu / plate were found. In the monitoring of surfaces and personnel uniforms, results <1ufc / plate were obtained. The packed ampoules were incubated for 14 days at two temperatures: 7 days at 20 ° C to 25 ° C and 7 days at 30 ° C to 35 ° C. At the end of 14 days, the contents of the ampoules were examined to detect any contamination. Finally, the aseptic filling process for small-volume injectables was validated, meeting the acceptance criteria.
ABSTRACT The objective of this study was to validate the aseptic filling process in Line N°3 of the Small Volume 1 (PV1) section of a National Pharmaceutical Laboratory, which includes aseptic connections for the filtration of solutions and aseptic operations in the process of packaging in 5mL colorless glass ampoules, using the Truking ampoule sealer and sealer using Digested Casein and Soy Broth solution and Thioglycollate solution instead of product. Before carrying out the aseptic filling process, the different variables of the process were taken into account to establish the worst-case conditions, such as: the speed of the packaging machine, the complexity of the operations, the primary packaging system, among others. In the filtration operation, a 0.2 µm capsule filter and a glass container were used to receive the filtered culture medium solution. During the packaging process, routine interventions such as the assembly of the packaging system, the connection and disconnection of the packaging system and the regulation of the dosage were carried out. Tests were carried out such as: contaminated units, sterility in bulk sample, obtaining sterile results. In the growth promotion test, consistent results were obtained in the three batches of culture medium. In the air environmental monitoring test, results <1 cfu / plate were found. In the monitoring of surfaces and personnel uniforms, results <1ufc / plate were obtained. The packed ampoules were incubated for 14 days at two temperatures: 7 days at 20 ° C to 25 ° C and 7 days at 30 ° C to 35 ° C. At the end of 14 days, the contents of the ampoules were examined to detect any contamination. Finally, the aseptic filling process for small-volume injectables was validated, meeting the acceptance criteria.
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Keywords
Llenado aséptico, esterilidad, medio de cultivo.