Pharmaceutical Client – Continuous Manufacturing Suites

The Need

A pharmaceutical client harnesses the power of biotechnology, chemistry and genetic medicine while urgently advancing science to solve some of the world’s most significant health challenges. The client asked MNA to help design a continuous manufacturing process. The process is a key component to the pharmaceutical client’s ability to conduct research regarding many types of diseases and areas of neuroscience. The design would be used as a prototype for additional sites.

THE CHALLENGE

The existing building would require redesigning new configurations for continuous manufacturing processes. Shelled spaces on the first floor would be utilized for the first and second levels of the process. The second floor would provide the third level of the continuous manufacturing process, which includes the excipient feeders. Active pharmaceutical ingredients (API) would be segregated to the first and second level processes on the first floor. Additional design accommodation would be necessary to allow for future conversions to Level III compounds, high potent API on all floors, decontamination, airlock and pressurization, and air filtration components.

The Solution

MNA provided architectural and engineering services for the detailed engineering and construction administrative phases for the continuous manufacturing project. MNA developed HVAC pressurization and ISO class requirements for various rooms within the suite. The layout and scope of work were developed to accommodate future provisions such as a capsule dispensing room located on the second floor, providing a nitrogen source for inserting mixers, Level III API compounds (limited to first floor), and automatic refilling of the feeders on second floor.

The project was the overall winner of the ISPE Pharmaceutical Facility of the Year Award (FOYA) and also recognized for its engineering effort by the International Society for Pharmaceutical Engineering.”

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