Restricted access barrier systems (RABS) are an efficient mechanism to avoid containment. In fact, they cover a large field of application in aseptic manufacturing.
This equipment provide a high level of separation between the operator and the aseptic core. In other words, direct human intervention in the processes is restricted by a combination of a physical barrier and a dynamic airflow. This makes it a viable and effective alternative for controlled production in a sterile environment. For this reason, we will show you everything you need to know about RABS.
What does RABS mean?
Restricted Access Barrier System (RABS), which function is to avoid the entrance of containment, acting as a barrier between the operator and the aseptic fabrication process. It is therefore considered an effective control measure to ensure product quality as well as to maintain high safety standards in sterile processes.
Each piece of equipment is adapted to the operating environment because it is designed according to the needs of each customer and the regulatory basis of aseptic manufacturing.
Classification of RABS
Restricted Access Barrier Systems are classified under two types:
Open System (Open RABS)
This system may be passive, i.e., using the cleanroom ventilation/filtration system, or it may have a dedicated air handling system independent of the room air supply.
Closed System, (Closed RABS)
They have a dedicated air treatment system, which can be recirculated inside the barriers or expelled into the clean room after filtering.
Applications
To improve product protection and also preserve the health of operators, it is increasingly common to adapt barrier systems with restricted access to manufacturing.
Under these criteria, RABS can also be applicated in related aspects with:
- Containment processes, where the product has a certain level of toxicity and its exposition has to be avoided.
- Aseptic processes, in which the sterility of the product must be maintained. In other words, the main objective is to protect the product from contaminants.
- Manufacturing processes involving both aseptic and containment conditions.
Generally, such processes are found in the pharmaceutical industry and in laboratories.
Advantages of RABS
- They ensure adequate product protection by providing a physical barrier to the process area.
- They help to avoid direct interventions by personnel in the process area.
- They are systems designed to meet all the requirements of aseptic processing.
RABS represent effective action measures to ensure product quality and enhance safety in aseptic manufacturing processes.
