The manufacture of medical and pharmaceutical products requires the application of equipment such as RABS systems to minimise contamination risks and protect the production chain as well as to ensure that medicines meet the expected quality criteria according to the conditions and requirements of the aseptic production operation.
Therefore, we will show you the advantages and disadvantages of using RABS systems in sterile manufacturing.
Advantages of RABS systems.
Restricted Access Barrier Systems (RABS) for the aseptic manufacturing offer the following advantages:
- Provide an aerodynamic barrier to the aseptic critical core.
- Minimise direct interventions by personnel into the critical zone.
- This equipment helps to comply with aseptic production conditions.
- They reduce the complexity of classified areas for high-risk products.
- They help to limit the frequency of environmental monitoring in processes.
- Increase levels of safety and quality control throughout the operation.
- Improve validation of production procedures in a sterile environment.
- Support compliance with regulations and standards.
In other words, RABS help to have a precise control of the operating environment. In addition to minimising the risks of contamination in the production stages.
Disadvantages of RABS systems
For the aseptic manufacturing, RABS offer the following disadvantages:
- The surrounding area or clean room must be class B to ensure optimum performance.
- RABS systems do not have the option to handle automatic cycles for decontamination.
- This equipment requires maintenance by qualified personnel in the area.
- The implementation of RABS can increase the operating cycle time.
- Management of strict cleaning procedures and control measures in the operational area.
- Increased energy costs by requiring higher rated cleanrooms.
Application of RABS technology
In aseptic operations, RABS technology provides a physical barrier and dynamic airflow. This ensures a sterile environment at all stages of manufacturing.
This technology has proven to be effective and compliant with regulatory requirements. In addition, its application helps to ensure quality and safety.
The key to all this is to manage advanced aseptic processing with the help of technology for effective and timely contamination control.
Undoubtedly, RABS systems offer multiple advantages in aseptic manufacturing. But they also show some disadvantages, which should be considered before implementation.
In view of this, Litek Pharma provides a specialised service for aseptic operations. This includes the provision of equipment and technical advice at every stage from experts.