An open operation RABS, 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 RABS have an air handling system that is shared with the cleanroom’s ceiling downflow with an air overspill to the surrounding environment. This overspill 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 to maintain a 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 means as a containment solution for processes such as, but not limited to, milling and sieving purposes.
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)
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