Background
ECI was contracted by a medical device manufacturer to enhance its production capabilities. This significant project involved remodeling the manufacturing facility and expanding the building to include a new Research and Development (R&D) laboratory, a tooling workshop, and improvements to facilitate efficiency in product transfer projects.
Approach and Solution
A Senior Project Engineer was engaged to support the client on a construction project, determining requirements and managing a detailed Project Charter. During the planning phase and strategy determination, new production requirements were defined which resulted in the management of multiple Project Charter’s. The ECI Project Engineer also managed the projects validation strategy based on the client’s internal procedures and the client’s cross functional team activities.
Comprehensive Action
Working with the client, the following building expansion and remodeling projects were completed:
• Constructed a new employee entrance, restrooms, gym and other common areas.
• A mezzanine was also added to create new clinical office space and IT main center.
• The mezzanine included a new R&D laboratory and the relocation of the Microbiology lab.
• The Tooling workshop was also relocated to a different space within the building.
• Two clean rooms were built to increase production capacity and new product transfer.
• ECI coordinated equipment selection, installation, and validation to support two new cleanrooms Class 10,000/ISO 7 and Class 100,000/ISO 8.
• ECI also coordinated equipment selection, installation, and validation to support new laboratories for R&D and Microbiology testing.
Approach and Solution
The project, which initially began as a construction management effort, expanded in scope to include managing all activities required to validate the new cleanrooms, R&D laboratory, and the relocation of the Microbiology lab and Tooling room.
A multidisciplinary team comprising the client's personnel from production, quality, microbiology, chemistry, regulatory, and research and development departments was assembled to support the validation plans. These plans were executed and led to the production of final validation reports.
ECI managed the client's team activities and coordinated with external suppliers to ensure all cleanrooms and laboratories met the necessary test requirements.
Results
ECI successfully supported and led the facilities project management from the planning phase through the entire two-year process to complete the facility expansion. Two distinct cleanroom validations were required due to differences in process characterization, both of which were executed successfully with no failures. The laboratories and their equipment were installed, validated, and are now fully operational. The facility updates also include additional common areas, offering the potential to further increase capacity. The project was completed on time, within budget, and met all quality standards.
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