Restricted Access Barrier Systems are very useful in sterile pharmaceutical manufacturing to maintain the sterility of the products.
The goal of a barrier system is to segregate people from the product so that certain pharmaceuticals are not exposed to certain organisms and useful in aseptic filling systems. RABS process in an ISO 5 environment, similar to isolators. RABS manually performs bio-decontamination. If the doors are ever opened, the system must be sanitized correctly, a line clearance must be performed, and the intervention recorded. RABS allows for faster start-ups and easier and quicker changeover.
Restricted Access Barrier Systems also can accept certain restrictions and offer increased operational flexibility. Most pharmacies choose RABS over Isolators because they are quicker in the changeover process. Like laminar flow hoods (LFHs), RABS feeds clean air from fan units through HEPA filters and air vents from the unit into the barrier system.
Air exits through small opening to the room at a low level. RABS provides separation by the barrier and positive airflow. RABS air handling is much simpler than the isolator because the isolator uses recycled and recirculated air. RABS usually are cleaned manually followed by a CIP unit to clean up commodities. This process is more simple than the cleaning process of an isolator, which includes bio-decontamination.
Environmental monitoring is necessary to ensure the ISO 5 environment in the system is working correctly. This monitoring is done by built-in sampling ports. In RABS, there is also an option to use a portable sampling device inserted at the floor level air exit opening. Restricted access barrier system RABS for aseptic manufacturing is a critical competent to any successful packaging operation.
Although there are so many pros, the regulatory issues must be considered as well. The RABS has a so called “open door” that could potentially compromise the aseptic environment and could be very harmful. Appropriate measures should be taken to ensure that the aseptic environment is maintained and that you do not have a leak. SOPs may be required to maintain the environment.
When implementing a RABS, companies must remember the system part of this technology. To successfully implement a Restricted Access Barrier System, engineers and maintenance personnel must ensure that it is integrated into its surrounding environment and that proper maintenance is provided to the system. It must have the correct surrounding building and room design, including HVAC and air-handling systems.
Proper disposal systems for bio-decontamination must be present, as well as drainage systems. Building system utilities can impact the system pressure controls. Management oversight is also a very important factor when implementing a RABS device, the company should have at least one member of a maintenance personnel that is able to manage and repair the RABS. Continuous system managing is a must have.
Related: Possibilities of Contamination in Sterile Products
RABS is a very successful and efficient system that is used in pharmaceutical, medical, chemical, and electrical engineering industries. RABS have proven to be more successful and convenient than the isolator. Open-door RABS are more likely to contaminate and release toxins into the air than closed-door RABS. With improved technology today, it is very unusual to see a sterile drug operation to be run without a barrier system such as a RABS.
