Our cleanroom facility is designed to provide flexible space for the development and manufacturing of your cell therapy product(s). It is comprised of three large ISO-7 cleanrooms and two medium ISO-7 cleanrooms, the latter are capable of positive or negative pressures depending on need. These units are built around a central ISO-8 hallway connecting the spaces via a dedicated anteroom and gowning area.
The cleanroom facility is designed with architectural features and finishes in accordance with US FDA regulations as well as international standards for controlled cleanroom manufacturing environments and aseptic processing.
In addition to the cleanrooms, the facilities contain separate USP797 and USP800 pharmacy suites, a dedicated shipping and receiving area, and a large, contiguous GLP lab adjacent to the cleanrooms.