Analyzing Mechanical Defect Variability in Tablet Manufacturing: A Comprehensive Investigation of Machine Performance Consistency

Abstract

This study analyzes mechanical edge defects in the production of pharmaceutical tablets by analyzing performance variability across three rotary tablet compression machines. This investigation evaluates defect trends across ten production batches for each machine using statistical quality control methodologies, including control charts. The initial results indicate that Machine C exhibits the highest variability, mainly due to turret vibration, while both Machines A and C exhibit indications of undetected die wear. Following resolving these mechanical issues, all three machines exhibited enhancements in process stability and reduced defects. These findings accentuate the importance of integrating statistical monitoring with preventive maintenance to improve manufacturing consistency and ensure product quality within pharmaceutical operations. Key Terms - Compression, Tablet Edge Defect, Maintenance.