Automation Project for Global Catheter Manufacturer

The Challenge

Many manufacturing clients struggle with reduced labor pool, cost of training and maintaining employees, space limitations, and quality issues from manual hand assembly processes. This provides an opportunity to consider machine automation and robotics, but the challenge is weighing the costs and payback or return on investment for those capital expenditures.

• Incorporating best practices and technologies from three uniquely different plants and production cultures required gaining the trust and confidence of long-term employees and leaders and through investigation of current practices to ensure nothing was missed in the transfer.
• We needed Lithuanian-speaking Engineers located in Europe and the US who would be willing to move back to Lithuania for the integration and commissioning stages. 
• The client did not have aseptic processing expertise or resources to undertake the project on their own.
• Changing gears from what started as an automation design and build project and migrated to a $40 million-dollar greenfield construction project.

Our Solution

The US corporate engineering team engaged Sterling to complete a feasibility study on the current situation at the EU Ireland plant and propose potential solutions. Sterling designs customized equipment and robotics to significantly increase production and decrease manual labor. Sterling prepared URSs to obtain quotes from several vendors on equipment to automate the product packaging. With this information and completing the cost savings and return on investment analysis, Sterling created a five-year Capital Plan with each year’s purchase and installation plan. Our stakeholders took this Capital Plan to their leadership, and it was determined that a change needed to be made, but the most economical solution would be to greenfield a new plant in Eastern Europe. 

Costs of operations and availability of affordable labor were much more favorable than their three current manufacturing sites. Since Sterling has experience in technology and equipment transfer, we were selected to mobilize a team of global and local engineers to support the decommissioning and recommissioning of production lines from the US, Ireland, and Denmark to Lithuania. We worked with the onsite engineers at each plant to incorporate their knowledge into training and work order instructions for the new plant. This project was five years from start to finish, but the tech transfer and new plant build took less than two years, well ahead of initial estimates and expectations.  

• Sterling has Engineers and MBA’s that have extensive experience in putting together capital plans and justifications.
• Sterling has a global team of engineers that can design equipment for custom automation or evaluate existing Original Equipment Manufacturers that would have the right equipment solutions.
• Sterling team can design, specify, and layout plans for an automated assembly cell.
• Sterling has a CVQ (Commissioning, Validation, and Qualification) team with FDA/GMP experience that can handle all the documentation needed for installation of an off the shelf or customized automation solution.