- Aseptic Fill Finish Facility
An existing client needed to expand an aseptic filling facility in Japan, adding a third filling line with an additional 150,000 vials/batch capacity, aligning it with U.S. standards.
The 25,000-square-foot retrofit included an incoming material JIT (Just in Time) warehouse (raw material, excipients and components) with gowning, dispensing and formulation, filling, washrooms and autoclave rooms, along with storage areas. Other functions included inspection (visual and leak detection), cold intermediate storage rooms and packaging areas spread between two operational floors, along with addition of the utility and HVAC systems for the shell space.
The design strategy included the most current aseptic design compliant with multiple international markets, cGMP architecture that supported efficient flow and prevented cross contamination, URS development for the filling line. Our team also addressed the implementation of upgrades to the existing clean utility systems in the plant, and incorporated the quality processes that tied directly into the existing packaging process line.
We led the identification and analysis of the current aseptic filling suppliers and provided the client with a recommended approach for technologies that anticipate future regulatory requirements such as 100% closed container inspection. We completed a study to determine the number of staff required to run the process with suggestions on optimal staffing. A constructability plan, fully integrated EPCmV schedule and construction cost estimate were also provided. The project was completed on time, within the base schedule and met the budget expectations.