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CLOSED RABS
Barrier technologies for aseptic fill-finish lines
Closed RABS is a barrier technology designed to separate operators from aseptic processes, ensure sterility assurance and adequate operator protection for mildly potent products while remaining a flexible, cost-effective solution
Closed RABS is a barrier technology designed to separate operators from aseptic processes, ensure sterility assurance and adequate operator protection for mildly potent products while remaining a flexible, cost-effective solution
Safety first, for both product and operator.
Closed Restricted Access Barrier Systems (Closed-RABS or C-RABS) represent an advanced evolution of traditional open RABS, combining aseptic process protection with a minimal degree of operator safety during the handling of mildly potent compounds. While open RABS are widely used in the pharmaceutical sector as a cost-effective barrier to separate the production area from operators and the surrounding environment, they offer product protection when airflow is active but no protection to personnel when potent products are processed. Closed RABS, on the other hand, enhance safety for operators, ensuring a first level of containment.
From a regulatory perspective, closed RABS share the same cleanroom background requirements as open RABS, typically operating in a Grade B (ISO 7) environment with an internal Grade A (ISO 5) zone around the critical process. This ensures alignment with international GMP expectations while maintaining flexibility in facility design.
Closed RABS are frequently employed in powder filling lines, as well as for the containment of external vial-washing machines and capping stations, where an additional degree of product and operator protection is required without compromising process efficiency.
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Sustainability
IMA has always been committed to reducing the environmental impact of its equipment, addressing the issue of consumption through design choices, high-efficiency components and optimising the control dynamics on processing machines such as barrier technologies (open RABS and closed RABS).
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Production Plant
IMA Life
CLOSED RABS Highlights
1.
Compliance: provides a physical barrier between operators and critical Grade A zones, minimising the risk of microbial and particulate contamination. The design reduces operator intervention and direct interaction with critical areas, in line with GMP Annex 1 and FDA requirements.
2.
First air design: maximises machine ergonomics, ensures unidirectional airflow and supports aseptic process management in full compliance with first air principles. Usually provided with anemometers for continuous airflow speed monitoring.
3.
Containment: they offer an adequate level of containment for production conditions involving medium toxicity risks or potential product dispersion, such as in powder filling operations.
4.
Overpressure and HVAC integration: unlike standard OPEN systems, they are maintained under appropriate overpressure and can be configured with a suitable pressure cascade. In addition, they can be supported by configurable HVAC systems to achieve the required temperature and humidity targets inside the chamber.
5.
Flexibility: fully configurable to suit any layout and machine configuration requested to meet customer’s need in terms of productivity and operational flexibility.
6.
High reliability: engineered for long-term robustness and stability of all functional parameters.
7.
Environmental monitoring: designed to support continuous environmental monitoring (e.g. viable and non-viable particle monitoring) directly in critical process areas with no need for open door interventions.
8.
Sustainability: designed to reduce energy consumption, operating costs, and the overall environmental and CO₂ impact on the facility
Closed RABS, are easily installed on top of any standard filling line for aseptic liquid and powder products. They remain a reference barrier technology, commonly applied across various manufacturing contexts worldwide.
- Machine Layout
