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.
Why was one floor’s laboratory ventilation failing to keep up, when it was even the closest floor to the rooftop fans? Some system sleuthing led two engineers to a fitting conclusion. Read more stories in May Issue 2017.