Open and Closed RABS by EREA Pharma – Safety First

The RABS, Restricted Access Barrier System, is a barrier technology that appeared in the 1990’s to separate personnel from the product, retain contaminants or segregate two areas. RABS allow to reduce or eliminate interventions in the critical area by installing rigid separations. Pharmaceutical industries can choose between open (active or passive) and closed RABS.

The latter is characterized by a closed system so that the product or material is not exposed to the environment of the room. It has a Class A (ISO 4.8) air quality unit and offers continuous and seamless isolation.

Overview of how RABS work

The restricted access barrier system operates on several key principles. First, it consists of a closed enclosure equipped with transparent panels that allow operators to view the operations taking place inside. This enclosure creates a physical barrier between them and the production area. This reduces the risk of cross-contamination.

The RABS is also equipped with high-efficiency particulate air (HEPA) filtration systems, which ensure strict control of the air quality inside the enclosure. These filters capture particles and microorganisms present in the air, preventing them from entering the production area.

The Restricted Access Barrier System also relies on the use of gloves integrated into the enclosure. These gloves help operators perform all necessary manipulations inside while maintaining the protective barrier. It should be noted that these gloves are in most cases equipped with puncture detection systems to ensure their integrity during various operations.

Finally, this barrier system is often coupled with advanced control and monitoring systems to ensure safe and efficient operation at all times. These systems may include pressure sensors, automatic disinfection devices and alarms to detect any anomalies or breaches of the barrier.

Open RABS

Open RABS with passive flow

The Open RABS with passive flow is characterized by an air supply that is dependent on the surrounding cleanroom filtration system (customer’s fan ceiling (FLV)). It has an air exhaust at the bottom. It is equipped with PETG doors with excellent visibility, and thanks to the interlocking of the doors, ERA guarantees increased safety for all your processes. The Open RABS with passive flow can be used for non-toxic products.

Open RABS with active flow

The Open RABS with passive flow is characterized by a HEPA-filtered air supply via its own filter station, integrated in the equipment. A laminar flow is integrated into the RABS, also covering the doors. EREA’s Open RABS with active flow also has an exhaust air zone at the bottom. It has PETG doors with excellent visibility that can be interlocked. The Open RABS with active flow can be used on non-toxic products.

The Closed RABS

The Closed RABS is a closed system with a hermetically sealed chamber with its own air supply and recirculation. It is used for highly active and cytotoxic products. Their design makes them similar to isolators.

Closed RABS with active flow

EREA’s Closed RABS with active flow incorporates a laminar flow, also covering the doors. It has on-board filtration/ventilation units. It is therefore able to provide HEPA, or High Efficiency Particulate Air, filtered air to the critical process before it is recirculated. As a physical barrier, it is equipped with tempered glass doors that guarantee a complete closure for enhanced safety.

It offers a negative or positive differential pressure, managed by an automaton.

It is designed for multipurpose use, i.e. sterile and toxic. All RABS closed systems can include glove ports, access doors with interlocks, RTP systems as well as EM systems.

Airflow innovation and simulation for EREA RABS

At EREA, we place airflow control at the heart of our RABS design. In fact, our goal is to ensure optimal containment while maintaining perfectly controlled environmental conditions for critical areas of pharmaceutical production. Our engineers therefore incorporate advanced laminar airflow and HEPA filtration technologies to ensure constant protection for the various products, operators and the environment.

Before any implementation, we carry out computational fluid dynamics (CFD) simulations to accurately analyse airflows, velocity distributions and particle dynamics. It should be noted that these models are essential for validating design choices and anticipating the actual behaviour of the system once installed. They also help to adjust flow rates, pressures and the configuration of supply and return air grilles in order to achieve a perfect balance between energy performance and microbiological safety.

The airflow innovations we develop directly contribute to reducing turbulence and optimising energy consumption. By integrating adaptive flow regulators and connected monitoring systems, we ensure perfectly consistent air conditions in all protected areas. This precision control enables compliance with Good Manufacturing Practice (GMP) requirements and the recommendations of Annex 1 of the European GMP.

Using this method based on simulation and digital engineering, we design high-performance RABS that can evolve with the needs of modern filling lines. Combined with our expertise in containment, airflow innovation is a central pillar of the reliability, durability and safety of our solutions for aseptic environments.

EREA: a Unique Know-how at Your Side

EREA has 2,500 m2 of workshop space, a highly specialized team, airflow simulation and 3D visualization software. Thanks to our clean room, EREA can carry out full-scale ergonomic tests. All our equipment is manufactured in France according to strict protocols.

EREA installs its containment systems all over the world and ensures their qualification. We take particular care to develop integrated solutions adapted to your needs. The EREA teams are at your service to answer all your questions.