Privatsphäre-Einstellungen

Zwischen Isolator und Sterilraum − Restricted Access Barrier System (RABS)

Johannes Rauschnabel

Robert Bosch GmbH, Packaging Technology, Crailsheim

Korrespondenz: Dr. Johannes Rauschnabel, Robert Bosch GmbH, Packaging Technology, Blaufelder Str. 45,
74564 Crailsheim (Germany), e-mail: johannes.rauschnabel@de.bosch.com

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.
These are some of the benefits: product safety is higher (compared with clean room operation); air conditioning and filtration is reduced to a smaller volume; improved operator comfort. But there are also disadvantages: for size part change, doors have to be opened; this means a time consuming bio decontamination cycle has to follow; the barrier makes handling and transfer processes more complicate and each isolator line needs validation of this bio decontamination cycle, which takes several weeks.
As an alternative to clean room and isolator operation a ’Restricted Access Barrier System’ „RABS“ could be applied. RABS show only a partial separation between sterile operation and environment: operators work within high grade air quality (at least ISO 7); transfers have to be performed with sterile transfer techniques − but devices could look more simple; the bio decontamination process can be substituted by easier to validate sanitation procedures; size part change and interventions due to machine crash need less time.

Key words Isolatortechnik • Reinraum • Restricted Access Barrier System (RABS) • Sterilabfüllung