Calificación de Operación y Desempeño (OQ y PQ) de la Tableteadora Stokes II del Laboratorio Tecnología Farmacéutica de la Escuela de Bioquímica y Farmacia de la ESPOCH Mediante la Compresión de un Placebo.

Abstract

The objective of the following work is to qualify the operation and performance (OQ and PQ) of the Stokes tablet press of the pharmaceutical technology laboratory of the Faculty of Sciences of the ESPOCH through the compression of a placebo, as excipients 73% dicalcium phosphate, 23% microcrystalline cellulose, 3% povidone and 1% magnesium stearate are used, a pilot batch of 1 kg was made by the wet granulation technique to then compress in the Stokes tablet press obtaining tablets of average weights of 600 mg. For the qualification, specific tests were carried out to verify that the equipment works according to its technical specifications, i.e., it is able to perform the function for which it was built, i.e., to compress and can perform effectively, based on the process method and the specifications of the product obtained. The quality control of the tablets was carried out by means of parameters of average weights (600 ± 5%), hardness (6-9 Kgf), friability (less than 1%) and disintegration (less than 30 minutes), which were found to be within the specifications. The statistical treatment showed that the hardness of the tablets does not vary at this confidence level (95%) and therefore the measurements are similar at the beginning of the process and at the end of the process, determining that the weights are not altered as the tablet press is in operation, thus demonstrating that the tablet press fulfills its function and tablets can be obtained with the specifications proposed.