Coating Process Improvements in Solid Dose Form Manufacturing

Abstract

Organization’s goals and objectives use strategic scorecards that include Quality, Economics, Speed and Culture to establish business metrics focused on building continuous future success and competitiveness to create value. As a result, manufacturing facilities are encouraged to adopt Lean Transformation to align to an organization’s priorities and goals. Assessments of the manufacturing processes in a single dose manufacturing facility and interviews with key personnel to determine potential opportunities were performed by means of Voice of the Costumer. Cycle Time Reduction for Color Suspension and Clear Solution Preparation was attained with a minor equipment modification that improved material reconstitution minimizing mixing time, air entrapment and foaming formation; thereby, reducing the deaeration time. Cycle Time Reduction for Line Flush was achieved by increasing (2X) USP Purified Water flow rate. Spray Gun Performance using an equivalence test between Pan Loads, Manufacturing controls and procedures evaluation and standardization of spray guns assembly supported the reduction of spray gun verification frequency. Removal of redundant documentation where automated systems are in place and verifications by a second person from non critical steps according to 21 CFR Part 211 Subpart F--Production and Process Controls reduced redundant documentation and head count. A 62% cycle time reduction (6.91 hrs hours from 11.4 hrs) per lot as well as 1 head count reduction ($43,680) were the immediate benefits attained from all process improvements. Key Terms - Critical to Quality (CTQs), Cycle Time, Voice of the Costumer (VOC), Waste, Coating Improvement, Solid Dosage Forms.