Aseptic and Sterile Drug Product Facility ONEsolution

Catalent, a contract manufacturing organization, wanted to expand its fill finish and packaging operations for growth of its aseptic and sterile drug product services. CRB provided basic design through construction documents and construction management for a ONEsolution^TM delivery of this renovation.

Approximately 55,000 square feet of warehouse and 20,000 square feet of the basement were demolished and replaced with a new building structure that includes an approximately 21,000-square-foot lower level, 56,000-square-foot main level, including a 22,000-square-foot clean core, 33,200-square-foot interstitial space and 29,000-square-foot penthouse levels.

The four-story renovation was designed to support new Class D and Class C clean rooms with formulation suites, two high-speed isolated filling lines to support aseptic vial and syringe filling, clean and prep suites and new process utility functionality, including water for injection, clean steam, clean compressed air, nitrogen and clean-in-place systems. New electrical switch gear, a 2,500-kilowatt generator, cooling towers, boilers, chillers and a liquid nitrogen storage tank were provided in the yard. The project also included support spaces and a new main client lobby.

One of the challenges of the project was that the building was not originally designed to support the aseptic manufacturing process. It was a single-story warehouse with light framing, so this section of the building had to be demolished and rebuilt. CRB’s design kept this activity restricted to the corner of the building, minimizing the impact on the remainder of it. This demolition and construction also created a project schedule challenge because the demo area was occupied until June of one year, and the facility had to be substantially complete by the third quarter of the following year. Innovative pull scheduling and coordination of activities were required to meet the project goals.