Fill and Freeze Dry Facility Expansion C&Q
Pharmaceutical Client
To support growing global demand for its trusted vaccines, parasite-control products, and pharmaceuticals, our client—the second-largest animal health company in the U.S.— undertook a major expansion of its sterile fill and freeze-dry (FFD) vaccine production
facilities. This strategic investment significantly enhanced the company’s manufacturing capacity for critical biologic products.
The project scope included the addition of a 6,000 SF cold storage warehouse, infrastructure upgrades to optimize material and personnel flow between new and existing production areas, and the installation of comprehensive new mechanical and electrical systems. These systems included HVAC, steam boilers, chillers, cooling towers, switchgear, emergency generators, and process utilities such as RO water, clean steam, compressed air, and liquid / gaseous nitrogen.
New process areas were constructed to meet stringent regulatory standards, including Grade A through Grade D cleanrooms. The facility was outfitted with a fully integrated fill line, lyophilizers, cappers, and associated support equipment—all of which were installed, commissioned, and qualified.
Our team provided end-to-end commissioning and qualification (C&Q) services, including building and process commissioning, development of commissioning and qualification plans, scheduling, and overall C&Q management. Leveraging more than 15 years on this campus, we were engaged early in the design phase to ensure alignment with our client’s production and
regulatory goals.
Despite the project’s fast-tracked schedule—from initiation in 2016 to completion in Q3 2019—our team delivered on time and to specification. Lessons learned during execution were captured and applied to improve future project delivery for the client.
The successful completion of this expansion not only increased our client’s production capabilities but also reinforced our long-standing partnership. The client expressed high satisfaction with our C&Q performance, leading to our selection for two additional large-scale projects and a further expansion of the FFD area.
