IsoKlenz® Isolators for Aseptic applications are designed & built to operate filling, stoppering, lyophilisation, capping and container transport under Grade A conditions within a background of Grade C/D. These installations typically surpass even the most stringent cGMP regulatory guidance. Going beyond limiting the processing perimeter as in the case of CRABS these isolators provide hermetics, bio-decontamination and advanced climate control. This process is therefore sustainable in Grade C/D settings and lowers the cost of clean room establishment and related management & qualification.