Syringe Filling Line Changeover Time Reduction by CIP Recipe Overlap with Product Transfer Recipe

Abstract

In a biopharmaceutical company, the syringe filling process is thru one of two filtration trains that must be previously washed with a cleaning in place and sterilized with sterilization in place. Therefore, while one train is transferring and filling product, the other train is preparing it with cleaning and sterilization. It was identified that when lots of 70,000 units or less and lots of Product R were filled, the stipulated changeover time of 4.75 hours was not met. A procedure stipulated that a transfer recipe could not run in parallel with a cleaning in place cycle causing a delay in the lot-to-lot changeover. An analysis by the automation department certified that the system was capable of handling both processes in parallel. The procedures were revised allowing the operator to perform both processes at the same time. After the changes, the stipulated changeover time was fulfilled and an increase of 3.3 million of additional units is projected for this year. Key Terms ⎯ Continue Improvement, Efficiency, Productivity, Waiting Time.