RABS-type isolator aimed at the food industry

The company says that RABS isolator represents a significant improvement in the aseptic filling sector. It optimises the aseptic conditions in and around the sterile enclosure and gives the operator more freedom and comfort when working.

Traditional isolators have several shortcomings: low air renewal rate in the enclosure, turbulent and uncontrolled airflow, difficulty in checking sealing quality. In the pharmaceutical industry, these shortcomings led to the development of the RABS type isolator and this same standpoint led Serac to design its system.

The company worked with the same criteria that the International Society for Pharmaceutical Engineering defined for the FDA for the RABS type isolator:

• Solid partition providing physical separation between production and the operators
• Unidirectional airflow - ISO 5
• Glove boxes or automation system to avoid access during filling
• Equipment transfer system to avoid exposure to less clean environments
• High level of surface disinfecting
• ISO 7 environment class
• Very few interventions, required

The operator, a primary source of contamination, controls the machine from the outside and the overpressure created inside the sterile zone prevents any risk of contamination.

Serac's system offers major improvements to the traditional isolator. Contrary to the traditional isolator, the RABS isolator is not hermetically sealed. The system is composed of an air barrier that generates a positive overpressure inside the enclosure to protect the sterile work zone.

A vertical unidirectional flow at a controlled speed enables continuous circulation and renewal of the air. Association of these two techniques offers dynamic protection of the sterile enclosure and enables both the elimination of possible particles present inside the enclosure and protection against the penetration of contaminants from the outside.

Constant air circulation extends the aseptic state time and enables production over 72 hs without the need for intermediate decontamination.

The sterile enclosure is surrounded by barrier zones, which are also subject to a unidirectional airflow. These barrier zones protect the sterile enclosure from the filling workshop.

The heart of the machine, the sterile enclosure, may only be accessed during production via the glove boxes located at critical points along the filling line. However, other zones such as treatment or line input and exit are designed to be easily accessible.

Access to and exit from the barrier zone is permanently monitored and recorded to provide efficient tracking of all operations. The barrier zones also serve as access zones to facilitate cleaning and maintenance of the machine.