Browsing by Author "Sanchéz Velasco, Luis Alberto"

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    Contribución a la implementación del control estadístico de proceso en la fabricación del medicamento difenhidramina en la empresa Laboratorio Farmaceutico Medillip, Bayamo, Cuba
    (Ecuador: Latacunga: Universidad Técnica de Cotopaxi: (UTC), 2012-04-23) Sanchéz Velasco, Luis Alberto; Otero Fernández, Mario
    The research was conducted in the Pharmaceutical Laboratory Company Medillip,Bayamo, Cuba. With the aim of contributing to the implementation of statistical process control. We started with a preliminary study on the production line of the drug diphenhydramine, with data from a production batch, corresponding to 24 hours. Characterization was performed stratified by the same work shift of 8 hours and conducting sampling every two hours. This process resulted in identifying the presence of production units that do not meet specifications. This also found no significant difference between shifts and time of sampling. Then we applied the control charts for the mean and the range, confirming previous approaches. From the control charts a study of process capability which showed that the Cp index reached a value of 0.57 (value below the reference value, 0.67), hence it is considered that the process is not suitable and require modifications. The Cpk index value 0.56, lower than 1.00, evidence that some of the specifications (388 996.81 ppm) do not meet specifications, representing a cost of non-compliance of the order of 221 728.18 Cuban pesos for each batch of one million units. Obviously cost is high and should be analyzed with respect to the monthly production and sales of the product so it can be analyzed more objectively. These results suggest the need for a study to identify the causes responsible for the deviation of the process, take measures for their elimination (decrease) with the consequent effect on costs of nonconformity.