Regulatory Considerations for RABS Implementation
Regulators encourage the use of restricted access barrier system (RABS) or isolator technologies. Such settings minimize direct human intervention in a process, reducing the risk of microbial ingress from operators.
Transition from a classic design based on grade-A or grade-B cleanrooms to an upgraded facility is not to be taken lightly.
Such a project would take significant time and effort to retrofit or replace aseptic manufacturing lines — requiring major financial investment.
However, because regulatory bodies have increased their expectations regarding aseptic manufacturing and use of available technologies, it might become inevitable that companies will be required to upgrade the most critical areas of their aseptic facilities.
The main difference between isolator and RABS technologies — each offering its own advantages and limitations — is that isolators have automated bio decontamination cycles.
RABS
RABS are a flexible and effective solution for aseptic processing, especially for existing clean rooms that need to improve their filling quality and for applications that require higher flexibility and adaptability.
RABS can be easily installed and integrated with existing equipment and facilities, without the need for major modifications or renovations.
RABS can also accommodate different types of products and formats, such as vials, syringes, ampoules, or bags, and can be easily switched from one to another.
STEPS FOR RABS IMPLEMENTATION
Risk Assessment:
Conduct a comprehensive risk assessment to identify critical areas in the manufacturing process where contamination is most likely to occur. This assessment will guide the design and implementation of the RABS system.
Design and Engineering:
Collaborate with experienced engineers and designers to develop a RABS system tailored to the specific needs of the manufacturing facility.
Validation Protocols:
Develop and implement validation protocols to ensure the effectiveness of the RABS system.
e.g. testing the system’s ability to maintain sterile conditions, verifying pressure differentials, and validating the performance of air filtration and sterilization components.
Operator Training:
Thoroughly train operators on the proper use of the RABS system. Emphasize the importance of adherence to standard operating procedures (SOPs) and the significance of maintaining aseptic conditions during the manufacturing process.
Routine Monitoring and Maintenance:
Regularly check pressure differentials, airflow patterns, and the integrity of physical barriers.
Implement preventive maintenance measures to address any issues promptly.
Read also:
- Difference Between RABS and Isolator
- Effectiveness Evaluation of Isolator Systems and Restricted Access Barrier Systems
Resource Person: BARBARA PIROLA
