The containment isolator is manufactured from 316L stainless. Trays of empty glass vials are presented to the filling machine accumulation table at the in-feed end of the isolator. The 270mm alpha flange assembly is located on the rear of the unit. Vials are individually hand wiped and placed into stackable transfer trays. Transfer trays are passed out of the containment isolator through a double-door airlock.
All manipulations occur through ergonomically placed glove ports.
The facility layout is made much simpler than that of an equivalent traditional potent drug fill suite through reliance on the containment isolator. The modular steel architectural elements are fully glazed and present a clean, open look that could not be easily achieved with conventional construction. An added benefit for this location is that when the steel architectural elements are fastened together, they provide both an inherently earthquake-rated envelope as well as a walkable ceiling grid. The envelope can also be readily dismantled for the introduction or removal of additional process equipment. Unlike traditional gypboard construction, the modular envelope is built rapidly under clean construction protocols, enabling a much faster start-up and commissioning for the facility.