Zwischen Isolator und Sterilraum − Restricted Access Barrier System (RABS)
Robert Bosch GmbH, Packaging Technology, Crailsheim
Korrespondenz: Dr. Johannes Rauschnabel, Robert Bosch GmbH, Packaging Technology, Blaufelder Str. 45,
Between Isolator and Clean Room − Restricted Access Barrier System (RABS)
For sterile filling of parenteral drugs filling equipment is traditionally placed into a clean room environment (at least ISO 7). An alternative approach is to reduce the clean room to the foot print of the filler. This can be achieved with barrier isolator technology, which implements a barrier together with a positive pressure to separate the aseptic area of high air quality (at least ISO 5) from a class ISO 8 environment. Operators have to use glove ports for interventions and for transfers between the inside and outside sterile transfer devices have to be considered.
Key words Isolatortechnik • Reinraum • Restricted Access Barrier System (RABS) • Sterilabfüllung
pharmind 2006, Nr. 6, Seite 767