Hazardous API Manufacturing Facility


Hazardous API Manufacturing Facility


Clayton, NC


- 92,000 SQ. FT.

- $55MM

- Assembly Lines

- Packaging Areas

- Warehouse

- Cold Storage


- Detailed Design

- Project Execution Plan

- Project Schedule

- Resource Planning Cost Estimate

- Mechanical, Electrical, Process + Process Control Design

- System Controls

- Project Management


RGD, OBA Architects, Flad & Associates, Yonkers Industries


Prefilled Insulin Pen Expansion

Our client intended to increase the assembly and packaging capacity for a Prefilled Insulin Pen at their production facility located in North Carolina. To support the capacity scale-up, HIPP provided a 92,000 square foot expansion design which included two new Prefilled Insulin Pen assembly lines, warehouse and packaging areas for the product. Designed to cGMP standards, HIPP’s design included documentation for space, equipment integration and utility requirements to support this effort. The second floor of this new two-story facility expansion was fitted with an elevator and offices for additional personnel in support of the new areas and production capacity escalation.

Transfer of Liraglutide to Clayton Site

To support their strategy for the liraglutide product, our clients required a backup source of filling, assembling, packaging and shipping to world markets. Two new 200-liter formulation vessels, specified by the client, needed to be installed. Professional design support to develop project planning and construction documentation for integrating these vessels into the manufacturing operation were required. HIPP partnered with a construction/project management firm in developing a project execution plan, project schedule, and resource planning cost estimate. HIPP provided mechanical, electrical, process, and process control design support as well as overall project management of all parties. We partnered with a structural design firm and an architectural design firm for support on this project. We also partnered with a systems control integration firm and a validation and commissioning firm for that phase of the project.

Packaging Line Expansion

Approximately 8,700 square feet of existing space in our client's high bay warehouse facility was up-fitted in order to install two new packaging lines and staging areas. HIPP partnered with Flad & Associates for structural and architectural design support to complete the multi-disciplinary design. Project was fast-track/design build. Design packages were staged to expedite design and construction schedules. We provided mechanical, electrical, and controls design support and served as design project managers with Yonkers Industries overseeing construction management.