successful design and realization of a validatable life sciences
cleanroom won’t happen by chance. Early and continuous
coordination and communication among all parties involved - from
process design and scale-up through cGMP layout, pre-construction
design review, commissioning, validation, and onsite inspection by
regulatory authorities - is essential. The time spent in design
optimization in the front end, well in advance of the “bricks and
mortar” stage, will be saved many times over.