Since the process scaling requirements can change over time based on capacity requirements, the process cleanroom suites often need to be added in phases. Therefore, having a cleanroom process suite design that is clonable is critical. And often, the decision to invest and scale-out may be fast tracked, requiring the additional cleanroom suites to be rapidly deployable. Utilizing a prefabricated offsite autonomous cleanroom POD system that can be pre-qualified in the factory ensures that the units will be fully functional once installed, reducing the time required to start up the new suites.
We understand that time is of essence. We have experienced this important fact in many of our cell therapy projects. Time is consumed in many ways but construction is generally the largest component. For that reason our customers chose G-CON’s off-site constructed cleanroom PODs, as these are built in half the time traditional infrastructures take and they are fully functional and prequalified. It is assured that the PODs are working when they reach your site.
With the new predesigned approach, we reduce or eliminate the typically required design time (6-9 months), build time (up to 6 months) and the qualification phase (2-4 months). This means capacities can be rapidly deployed for clinical material purposes or commercial capabilities.