What is the difference between RABS and isolators?

Isolators include an automated bio-decontamination system and are suitable for long-lasting campaigns. A RABS, on the other hand, is an appealing solution for cleanrooms and guaranties the quality needs for applications which require more flexibility.

What is open RABS?

RABS means Reduced Access Barrier System, it is a rigid protection made of transparent walls (polycarbonate or glass), equipped with an adequate number of glove flanges and gloves. It is installed on top of the filling and/or capping machines, separating them from the surrounding area.

What is C RABS?

RABS or C-RABS (Closed RABS) are a type of restricted access barrier systems for aseptic processing of pharmaceutical products that reduces or eliminates interventions into the critical zone providing: unidirectional air flow systems (to reach a class A environment to the critical area);

Which is better an isolator or a RABS system?

On the other hand, running costs (e.g. gowning, environmental monitoring, etc.) are much higher compared to isolator systems. The initial investment of an isolator system is due to the dedicated biodecontamination as well as process air handling equipment on a higher level.

How are RABs and isolators used in aseptic processing?

During the last 2 decades, aseptic processing has advanced with the use of isolators and Restricted Access Barrier Systems (RABS) as a means of detaching the operator from “critical areas” thereby reducing potentials risks in products. These systems have been slowly replacing traditional cleanroom.

How are gloves secured on a RABS isolator?

Glove port access for personnel is standard with RABS. Glove ports, sleeves and gloves are secured to the walls using well designed and reliable seals. Pre-sterilized equipment and parts are introduced using aseptic procedures including available built in transfer systems and double door airlocks.

What do you need to know about RABS?

RABS Definition ISPE Definition: Restricted Access Barrier Systems (RABS) for Aseptic Processing A septic processing evolved in the 1980s and 1990s Introduction with the use of isolators to separate the operator from the “critical zone” and thus reduce product risk.

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