Equipment Replacement with a Stopper Processing System

Maintaining low manufacturing cost is increasingly difficult as product patents expire, industry regulations change and outdated equipment requires replacement. Companies are challenged to adapt production facilities and equipment to meet the changing environment, while continuing to manufacture product and conduct daily operations. In this case study, older stopper washing / sterilizing equipment was replaced with new stopper processing equipment, in an existing facility. The equipment manufacturer was challenged with the design, manufacture, installation and qualification of new equipment, while maintaining the same footprint of the original equipment, doing so as efficiently and economically as possible. Customization of the stopper processing equipment allowed for combining multiple processing steps to be completed in the existing footprint. The new equipment is capable of the following process steps: ergonomic stopper loading into process vessels; stopper washing, sterilizing, drying, and cooling; stopper storage in pressurized vessels; stopper transfer into bags, using bag filling equipment under laminar airflow. The stopper processing system includes the following equipment: mobile vessels, washing/sterilizing station (complete with articulating arm for stopper loading and transfer), and bag filling equipment. This case study demonstrates how flexibility in the design and engineering of the equipment allowed for the unique project requirements to be met. Key Objectives: • To describe the equipment replacement process, including design, engineering, manufacture, installation and qualification • To compare the new stopper processing system to the original, with respect to cost, throughput and quality assurance • To describe the new equipment processing steps • To discuss the customizable possibilities of the stopper processing system • To define regulatory requirements for stopper processing and how they are achieved