An open operation RAB, by definition, provides recognition that the barrier doors can be opened for operator intervention(s), at defined risk assessed stages during aseptic production operations, after the last bio-decontamination step. Open operation RABs are further characterized:
Type 1: Process Intervention
(highest contamination risk)
Type 2: Set-up Intervention
(high contamination risk)
Type 3: Inherent Closed Barrier Interventions
(lowest contamination risk)
Open design RABs have an air handling system that is shared with the cleanrooms’ ceiling down flow with air an overspill to the surrounding environment. Overspill air is directed to a low level under the physical glove-barrier screens and below the points of critical operation, typically 300 mm below and away from the point of fill. Transfer devices may include closed or aerodynamic protection at the device-barrier connection location and maintain closed separation to the surrounding environment during the transfer procedure.
oRABS are used to incorporate filling line equipment both for aseptic and potent products processing. This equipment is a very practical to meet most of the containment solutions such as but not limited to milling and sieving containment purposes.