Restricted Access Barrier System

What Does Restricted Access Barrier System Mean?

A restricted access barrier system (RABS) is a physical barrier installed between employees and the manufacturing process to prevent contaminating the product. RABS are used in aseptic manufacturing like pharmaceuticals to ensure a controlled product.

Safeopedia Explains Restricted Access Barrier System

Some products like certain electronics, pharmaceuticals, and aerospace components need to be manufactured in a sterile environment. Facilities employ various measures to prevent the introduction of contaminants, including gowning rooms and air showers. Within the sterile room, additional measures like restricted access barrier systems are necessary for attaining the highest level of contaminant control.

The Importance of Restricting Access

For the safety of patients, it is necessary that medical products be filled and packaged in sterile conditions.

Although it is impossible to eliminate the human factor from the manufacturing process, the use of sterile cleanrooms, isolators, and RABS can be very effective. Materials can be introduced or removed through glove ports depending on the level of containment required. Restricting access by installing physical barriers also helps to prevent accidental encroachment into sterile areas.

Types of RABS

Restricted access barrier systems are categorized according to two types: open (oRABS) and closed (cRABS) systems.

• oRABS can have a dedicated air handling system, completely independent of the room’s air supply, or a shared one, with the cleanrooms downflow that recycles air from the surrounding environment. The barrier doors of an oRABS can be opened to allow the operator to intervene at defined risk stages.
• cRABS has a dedicated air handling system that will circulate within the barriers and utilizes a gaseous decontamination system. It provides a higher level of contamination control as the barrier doors remain closed.

Configuration of RABS

The configuration of RABS includes:

• ISO Class 5 environment with unidirectional airflow
• Rigid wall enclosure
• Use of glove ports, half suits, to access all areas of the enclosure during filling operations
• Sterilization-in-place (SIP) is preferred for contact parts (fluid pathways)
• Materials coming from the outside environment must undergo autoclaving prior to RABS entry via aseptic transfer ports
• Highly automated processes and well-defined procedures for rare open-door interventions

RABS Best Practices

To ensure the successful operation of RABS, best practices should be followed, including:

• Prevent open door intervention
• Use a glove portal system to install all machine parts
• Ensure a high level of disinfection
• Test gloves for integrity and proper sterilization
• Establish an aseptic transfer process for moving between zones