Publisher's Synopsis
The design and construction of a sterile product facility for the manufacture of pharmaceuticals is a complex undertaking that involves many considerations not typically encountered when building more traditional pharmaceutical facilities. Focusing on proven fundamentals, this book explains the unique facility design needs of sterile product manufacturing. Containing numerous charts, graphs, tables, and sample forms, the author covers sterile facility design and project management from A to Z. Topics include: project formation, defining the project team, facility programming, project control and costing, and GMP requirements and their impact on architectural design and construction.