Process analytical technology is considered to be a system for designing, analyzing, and controlling pharmaceutical manufacturing to ensure final product quality. This research, therefore, utilized the process analytical technology framework to improve the performance of tableting process. Two main responses are of main interest including hardness and weight. At initial factor levels, the
charts are established and found in control for both responses. However, the process capability index,
, values are calculated to be 0.42 and 0.51 for hardness and weight, respectively. Moreover, the multiple process capability index, MCpm, is 0.46. These values indicate that the tableting process is incapable of producing quality tablets. The L27 is used for conducting designed experiments. The weighted additive model in fuzzy goal programming is then used to determine optimal factor settings. Confirmation experiments are then conducted at optimal factor settings. It is found that the
values are calculated to be 2.13 and 1.85 for hardness and weight, respectively. The MCpm value significantly improved to 1.99, which means that the process is highly capable. Consequently, the T2 and the sample generalized variance control charts are established and further used for monitoring future production. In conclusion, the tools used in the process analytical technology framework are found effective for improving the performance of tableting process.
