Article Posted: May 11, 2021
Grand River Aseptic Manufacturing (“GRAM”), a leading injectable contract development and manufacturing organization (“CDMO”), was awarded the 2021 Facility of the Year Award for Special Recognition of Operational Agility: COVID-19 by the International Society for Pharmaceutical Engineering (ISPE). GRAM received the distinction for the design and efficacy of its 60,000 sq. ft., world-class, large-scale fill/finish facility in downtown Grand Rapids, Michigan.
Midwest Cleanroom Associates designed and built the approximately 8,000 sf cleanroom inside the 40,000 square foot facility (European Grade C cleanliness level). Scope included Architectural, Mechanical, and Electrical elements of the cleanroom.
GRAM designed the fill/finish facility from the ground up with a focus on safety, capacity, and flexibility. Employee safety, exceeding regulatory requirements, and client needs stayed at the forefront by choosing best-in-class technology and facility design solutions first, then building the facility around to support. One-way material and people flows were incorporated to ensure product integrity, client viewing rooms with windows directly into formulation and fill suites were included for transparency, and top of the line equipment was installed to provide flexibility and Current Good Manufacturing Practices (CGMP) to serve a variety of client needs. The West Michigan CDMO overcame geographical challenges and fast-tracked the project to complete construction months ahead of schedule. This accelerated timeline enabled GRAM to open the pharmaceutical manufacturing facility in June 2020 at the height of the COVID-19 pandemic, leading to a contract with Operation Warp Speed and Johnson & Johnson.
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