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Open Restricted Access Barrier System

Rabs Open Restricted Access Barrier System

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)