Closed Restricted Access Barrier Systems (cRABS) are equipment designed to provide a high level of aseptic quality. They are designed according to customer needs and process regulatory requirements. They represent an efficient alternative to prevent product contact with particles or microbial impurities in different applications, mainly related to aseptic manufacturing.
In the following, we will show you each of the aspects related to cRABS.
What is a cRABS?
A closed RABS is a positive pressure system with built-in filtration units. The air once it has passed through the protected zone is filtered before being expelled into the clean room or recirculated to the system’s air inlet again.
Throughout the process the system doors remain closed, and therefore safety levels during production are maintained.
Applications of CRABS
CRABS are equipment intended for the manufacture of sterile products, which may have a slight level of toxicity. In this case, protection is achieved through a physical barrier between the operator and the product, in addition to the application of a laminar airflow system. Since the system controls the entire air flow (inlet and outlet), it allows for proper control of the pressure inside.
As already mentioned, CRABS are protection systems designed with the needs of the individual customer in mind. In addition to the normative criteria of aseptic production.
Depending on the requirements and design, these systems can be equipped with the following elements:
- Integrated ventilation module for recirculation.
- LED lighting.
- Doors with glove access.
- Chamber made of stainless steel.
- Automation and monitoring control.
- Alarms and interlocks to provide greater control and safety.
In this context, cRABS can be effectively adapted to filling lines for pharmaceutical sterile products where the environment classification for sterile processing is ISO 5 or class A, considering the following:
- Control of parameters (particle level, humidity, pressure, temperature).
- Laminarity of the flow covering the product.
- Air renewal.
- Cleaning, waste handling and decontamination procedures.
It should be noted that CRABS internally ensure a Class A environment. However, the surrounding area must be class B or higher.
Advantages of cRABS
- Enable a higher level of protection against the introduction of contaminants into the critical aseptic core to be managed.
- Increase levels of control in sterile processes.
- Direct contact with the operator is excluded to ensure product protection.
- CRABS are adapted to the needs and regulatory criteria of aseptic manufacturing.
- They have a closed air flow system.
Ultimately, CRABS represent an effective solution that promotes the improvement of aseptic processes. They provide a higher level of contaminant control and safety by providing containment with a completely closed airflow system. In addition, they restrict direct interaction between the operator and the product during the process.