New 185,000-ft2 Facility Expands cGMP Manufacturing Capacity
Deliverables: Conceptual and Schematic Design Packages
A global supplier of silicone-based medical devices, this client was faced with limited production capacity at its single manufacturing facility. When the company decided to triple its capacity by building an additional plant, mapping the current manufacturing process became a critical mission. Complicating the project scope, the owners of the manufacturing process were unfamiliar with technology transfer methods and process documentation was very limited. In addition, the devices were manufactured using customized equipment that did not come with standard documentation. Committed to building the additional facility, the client hired DME to solve these issues.
DME started by sending a team to the original plant to reconstruct the process. In doing so, they quickly gained the trust of the client’s employees and were able to create process flow diagrams, material balances, and equipment schematics—all of which would be incorporated into the new facility design. DME provided the programming, building design, equipment arrangements, as well as the conveyer layout and integration with the custom equipment. All of this was incorporated into the facility design package. A design-build firm local to the new location implemented DME’s design.
DME continued to stay involved, supporting the process portion of the project through construction. In the words of the management team, “we would have been lost without the talent and patience of our colleagues at DME.”
Of note: Solvents are used in the product of this medical device and therefore explosion proof ratings are mandatory in the factory setting. DME has special expertise in this area because of its work in the chemical and API process industries.