Abstract

Between isolator and cleanroom – Restricted Access Barrier System (RABS)

For sterile filling of parenteral drugs equipment is traditionally placed into a cleanroom environment (at least ISO 7, EU GMP Guide: Grade B). An alternative approach is to reduce the cleanroom 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, EU GMP Guide: Grade A) from a class ISO 8 (at minimum; EU GMP Guide: Grade D) 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 cleanroom 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 needs several weeks. As an alternative to cleanroom and isolator operation the 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; EU GMP Guide: Grade B); transfers have to be performed with sterile transfer techniques – but devices could look more simple; a bio-decontamination process could be applied, but also substituted by easier to validate sanitation procedures; size part change and interventions due to machine crash need less time.