DIGITALIZATION OF TABLET HARDNESS TESTING FOR ENHANCED EFFICIENCY AND PROCESS SIMPLIFICATION IN THE PHARMACEUTICAL INDUSTRY

Abstract

This study investigated the digitalization of tablet hardness testing at KALBE, which align with the Indonesian Government Making Indonesia 4.0 initiative. In the traditional system, hardness testing creates production bottlenecks that are simulated by Tecnomatix Plant Simulation, requiring 42.24 hours or 37% of the total cycle time of 4.72 days. The company aimed to reduce its cycle time to 4 days. To achieve the target, the MicroNIR OnSite-W digital tester was integrated with MATLAB analytics under the DMAIC methodology. ANOVA was used to test tablet consistency of tablet samples across three batches and tablet positions, while decision support was provided by the Analytical Hierarchy Process (AHP). The results showed a dramatic improvement, with testing time reduced from 42.24 hours to 0.24 hours (>99% reduction), while ANOVA confirmed consistent performance across operators and testing modes to establish SOP. The AHP analysis showed a strong preference for the digital method, and ROI calculations indicated a payback period of approximately 1.2 years, despite a negative initial ROI (–14.63%) due to the high capital investment.