By Maik W. Jornitz, President, G-CON Manufacturing LLC
Currently the need of a paradigm shift in the facility design of pharmaceutical and biopharmaceutical production sites has been stated in multiple papers and conferences (1, 2, 3). The reasons for such facility layout changes are manifold and, for example, can be newly evolving drug developments, changes in process technologies, transformation of the treatment or patient base or purely economic reasons, which focus on capacity utilization and process flexibilities. Ultimately, there is a change process happening, a shift from large area, product dedicated brick and mortar facilities to more versatile but multiple facilities in different regions.
With that new demand by the industry comes the promise of the delivery of the expected, in the form of “flexible facilities”, “modular facilities” or ”manufacturing on demand”. This article will review “the tools in the toolbox” of facility designs, especially ones labeled modular or flexible or both. A serious review of the promises and statements made might be of value.