Discussion and Summary
The analysis of Process Capability of tablet compression process through the use of statistical control charts examines different parameters. Some of the parameters examined by the selected critical process step and quality control steps include; premix blending time, the drying time and method, oscillator screen size, comminutor screen size, loss of drying or granulation, final mix blending time and, final blend (Agalloco and Frederick 80).
The analysis reported a consistent value of the premixing test. This indicated the level of efficiency of the process’s ability to maintain the components of premixing blending time within its performance limit. The powders were mixed for 20 minutes which was within the limits presented by the batch record (Agalloco and Frederick 80). The wet milling step reported the same results as the premixing test- a further indication of the process’s ability to maintain the parameter within its performance limit.
The average drying time for the oven tray process was reported to be 19.2 hours. Similar to the other parameters, this parameter reported positive outcome within the specified performance time limit ranging from 16 to 20 hours. The mean moisture content of the process was reported to be 1.2 percent (Agalloco and Frederick 81). Additionally, the test did not report any seasonal influence. Out of the 30 batches of final mix blending, 20 batches were mixed for ten minutes for ten minutes while the rest were mixed for fifteen minutes. The data of the test were represented in different histograms. The uniformity of the blend indicated a tightly grouped population. As a consequence, the process utilized in this analysis can maintain the parameters of their specification time.
Product capability model is a model used to evaluate different development parameters and processes used in validating both finished products and models. The model was used to evaluate table compression. It outlined different parameters for the study including tablet, thickness, hardness, weight, diameter and content uniformity. These parameters formed the critical quality attributes for the study. On the other hand, the study employed the following as part of the critical process parameters; homogeneity, compression force, speeds of the compression machine and flow rate of the powder.
Works Cited
Agalloco, James P, and Frederick J Carleton. Validation Of Pharmaceutical Processes. New
York: Informa Healthcare, 2008. Print.
