of Modern
Cleanrooms
Conceptual Design
Allows the creation of process diagrams,
floor plans and building estimates. This
allows for location decisions and
assessing local infrastructure.
Detailed in the Basis of Design (BOD)
document.
Includes HVAC systems, utilites, project
schedule and validation programs
Manufacturing logistics is determined
based on dose form, market projections Deliverables of conceptual design:
and output requirements process descriptions
equipment lists
Fill/Finish facilities, downtime & room layouts
maintenance are essential material flows
Design Consideration in
concept design
Access corridors - facilitate
material movements and
personnel facilities.
Personnel access - restricted
to essential personnel near
the process.
Primary and secondary
gowning areas need to be
contiguous.