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La Investigación Del OOS Comenzo Con La Revision Del Muestreo El Metodo y Los Equipos Utilizados para La Prueba de Dureza
La Investigación Del OOS Comenzo Con La Revision Del Muestreo El Metodo y Los Equipos Utilizados para La Prueba de Dureza
se revisaron ademas las otras posibles causas como la ganancia de peso, tiempo y temperatura
de secado y enfriamiento, perdida por secado entre el inicio del proceso en nucleo y fin del
proceso nucleo recubierto, donde no apreciamos ninguna causa critica para los valores bajos
de dureza
finalmente despues de nuestra evaluación de los resultados en los 3 lotes nos centramos en la
dureza de los nucleos que debido a la especificación nos permite trabajar en un rango entre
40-80N tenemos valores entre 40 y 60 N que tienden a bajar durante el recubrimiento por
debajo de 50 N con lo que se cerro nuestro oos interno, sin embargo tomando en cuenta sus
comentarios se esta planificando las respectivas pruebas para evaluar la velocidad del
durometro y el secado de las tabletas recubiertas factores que pueden ser variables que
causen impacto en el valor de dureza del equipo.
The OOS investigation began with the review of the sampling, the method and the equipment
used for the hardness test, the correct operation, qualification and calibration was verified,
one of their questions was whether the durometer if the speed can affect the hardness value,
according to IPC analysts have calibrated the equipment at a standard speed for all products
where no problems have been found during breakout.
As the next phase of the investigation, the operation of the compression and coating process
was reviewed, where the data that I shared by email was evaluated, where we identified the
tendency to lose 10 points of hardness after the coating process.
In addition, other possible causes were reviewed, such as weight gain, drying and cooling time
and temperature, loss due to drying between the beginning of the core process and the end of
the coated core process, where we did not appreciate any critical cause for the low hardness
values.
Finally, after our evaluation of the results in the 3 batches, we focus on the hardness of the
cores, which, due to the specification, allows us to work in a range between 40-80N. We have
values between 40 and 60N that tend to drop during coating by below 50 N with which our
internal oos was closed, however, taking into account your comments, the respective tests are
being planned to evaluate the speed of the durometer and the drying of the coated tablets,
factors that may be variables that cause an impact on the value hardness of the equipment.