Coating Process Improvement

Abstract

An increase in the number of events associated to AQLfailure that resulted on partial batch rejections was observed in 2020 for Tablets/Caplets formulations due to cosmetic conditions such as bump on coating, color blotches, pits on tablets, rough coating, lack of gloss, and odd shape tablets/caplets appearance. This report summarizes the coating improvements and recommendations identified to reduce the amount of pans inspected/rejected caused by aesthetical conditions. To improve the quality of process outputs identifiedthe team selected a quality managementmethod DMAIC (Define, Measure, Analyze, Improve, and Control). After using the methodology, the purpose of improving the cosmetic appearance of the product and decreasing the impacted pans was achieved. Data presented a significant reduction of pans inspection and rejection. Tablets pans impacted was reduced from 2.8% to 1.7%. Caplets pans impacted was reduced from 1.7% to 0.2%. KeyTerms⎯Coating, Improvement, Defects.