The design and construction of RABS systems considers aseptic process regulations and customer requirements in order to adapt the equipment to the operating environment.
Restricted access barrier systems act as a control measure in the pharmaceutical industry. They prevent direct interventions of personnel in the critical area through the implementation of a physical barrier and a dynamic airflow.
For this reason, we will show you what key elements are considered in the design and construction of RABS systems.
Elements of aseptic processing systems
The proper functioning of RABS systems within the pharmaceutical industry is subject to the following elements:
- Equipment designed under aseptic process regulations. Where a barrier to prevent direct human intervention and ISO 5 airflow is considered.
- Effective cleanroom design in order to maintain an ISO 5 environment in the critical area.
- Cleaning and waste management practices.
- Control and monitoring of environmental variables.
- Definition of automated processes.
- Accurate procedures for operations.
Design of RABS systems
RABS systems provide an adequate level of separation between the operator and the product in order to protect product quality and the safety of both personnel and consumers.
There is no single design for these systems, however, there are quality criteria to be considered:
- Rigid wall enclosure, to provide complete separation between aseptic operations and personnel.
- Filtered unidirectional airflow system providing an ISO 5 environment to the critical zone.
- Interlocked access doors.
- Glove ports or automation for safe handling.
During the design of this equipment, a Risk Assessment is required to identify the needs of the system. The size, containment level and workflow must be taken into account as well as other aspects such as materials to be used in the construction of the system and the location of the components.
Construction of RABS systems
Once a design has been drawn up in accordance with the quality criteria and requirements of the project, it is necessary to evaluate which materials, elements and procedures are to be used for the construction phase.
For RABS systems, materials with high wear resistance and durability should be considered. The aim is to ensure optimal operation and to make the most of the equipment’s service life.
Ultimately, the design and proper construction of RABS systems is subject to aseptic processing criteria. This requires a team of experts in controlled contamination and the application of modern manufacturing techniques.
Litek Pharma offers a complete technical service, depending on the needs of the customers and each project, as well as the regulatory requirements.
