RABS for Pharmaceutical Industry

Restricted Access Barrier System (RABS) for the Pharmaceutical Industry

Restricted Access Barrier Systems, or RABS, are bacteriologically enclosed equipment that create a controlled environment for the processing of sensitive and/or hazardous products. With RABS, operators can handle various types of substances in the sterile area, protected from particulate, chemical and microbiological contaminants in the outside air. The systems also allow for the handling of products that may be harmful to the operator’s health, such as toxic, sterile, radioactive or infectious substances.

EREA offers the Open RABS with passive or active flow (for non-toxic products). We have also developed the Closed RABS, which is characterized by a closed system, a hermetically sealed enclosure, and has its own air supply and recirculation system.

Do you operate in the medical, pharmaceutical or biotech field? Then EREA’s restricted access barrier systems will meet your needs. Our range of RABS ensures total protection. Containment is respected, while bringing flexibility to your line and cleanroom configurations. The traceability of interventions and door openings are also guaranteed.

RABS EREA, Safety First

Restricted access barrier systems are part of the solutions manufactured and offered by EREA. Our products stand out from the RABS currently on the market because they offer a high level of security. Furthermore, EREA is able to equip your restricted access barrier systems with an automatic leak detection system at the level of the cuffs and gloves. All these solutions ensure the safety of the products handled and protect the health of employees from dangerous products.

In addition to offering a high level of safety, the EREA RABS allow you to reduce your budget dedicated to the installation of a confined environment. Compared to clean rooms, RABS are less expensive. In addition, maintenance is economical. Finally, EREA’s RABS guarantee you a gain in productivity thanks to the reduction of time spent on cleaning, sterilization and changing clothes.

Strict compliance with Annex 1 of GMP 2022-2023: How the update of Annex 5 impacts RABS applications in the pharmaceutical industry

The restricted access barrier system is one of the solutions proposed by Good Manufacturing Practice or GMP to guarantee the quality of medicines. This is a regulation governing the manufacture of pharmaceutical products. A new version was drawn up in 2022 and has been in force since August 2023. This is the revised Annex 1. It is more demanding in terms of compliance with sterility conditions in order to ensure product quality, avoid over-frequent product recalls and better protect consumers.

Annex 1 of the FPG introduces a number of changes. It highlights quality risk management (QRM) and contamination control strategy (CCS). Pharmaceutical companies must take these two points into account when carrying out their various processes. If RABS for the pharmaceutical industry is validated by the revised GMP Annex 1, it is because it also wishes to integrate new technological advances into the improvement of the manufacturing process for sterile products.

Evolution of RABS applications to meet the requirements of Annex 1 of GMP 2022-2023

RABS is an innovative solution for carrying out pharmaceutical processes under sterile conditions. It replaces the old cleanroom, which is more expensive, less efficient and more difficult to maintain. The restricted access barrier system is the evolution of the cleanroom. It offers a better level of sterility assurance (SIA). It has the advantage of being more efficient thanks to the fixed, rigid barrier it is equipped with. It is also more economical and easier to maintain.

Successful integration of RABS at EREA Pharma for state-of-the-art aseptic pharmaceutical manufacturing.

EREA, Solutions for the Pharmaceutical Industry

For your RABS installation project for sterile applications, trust EREA. We are a company specialized in the design and manufacture of pharmaceutical solutions. Thanks to our technical skills, we provide efficient and effective containment systems.

EREA provides you with customized restricted access barrier systems. Before designing them, we take into account a number of parameters, such as your needs, the products you wish to process, the level of sterility you expect. For better operational efficiency, we can also automate their operation by equipping them with Panel PC or HMI solutions.

Need a quote for RABS for the pharmaceutical industry? Do not hesitate to contact us, our experts will quickly provide you with a free, personalized and non-binding quote.

FAQ about Pharmaceutical RABS

What is the difference between a pharmaceutical RABS and an isolator?

The RABS and the isolator are two pieces of equipment widely used in the pharmaceutical industry. Although there are similarities between the two, they are not identical. RABS for the pharmaceutical industry is a barrier technology. A fixed, rigid separation is placed between the operator area and the critical process area. However, this separation is not strict and the environment remains identical to a conventional room. The Isolator, on the other hand, creates a controlled aseptic containment space in which the critical stages of the process take place with maximum safety. It incorporates a decontamination system with a sporicidal agent (H2O2) that guarantees decontamination of all internal surfaces, further controlling the risk of contamination.

What should I choose between a pharmaceutical RABS and an isolator?

There are a number of parameters to consider when choosing between a pharmaceutical RABS and an isolator. In addition to regulatory requirements, you also need to take into account product toxicity, system flexibility, overall installation and running costs, production start-up time, energy consumption and operator training time.

What is the difference between active and passive flow pharmaceutical RABS?

A passive-flow pharmaceutical RABS has no dedicated air system. Instead, the air flow in the enclosure comes from the outside via integrated fan and filter systems. The equipment is said to be active if it has an air ventilation system that is independent of the production room airflow.

How do I get a pharmaceutical RABS?

The best way to install a restricted access barrier system is to contact a designer and manufacturer of containment solutions, such as EREA. They can provide you with a tailor-made pharmaceutical RABS that takes account of your specific requirements.