France-based Serac says its new restricted access barrier system (RABS) isolator, the SAS 3,increases productivity by allowing up to 72 hours of non-stop production without intermediatedecontamination periods. The SAS 3 allows filling rates of up to 50,000 bottles per hour to beachieved, the company claims.
Serac says the SAS 3 offers three major improvements over the standard isolator. It can cater forunidirectional flow, barrier zones, and easy access, while preserving the advantages of using anisolator.
Though standard isolators are hermetically sealed, the RABS isolator is not, Serac stated. TheSAS 3 is an air barrier produced by positive overpressure inside the enclosure that protects thesterile area.
Air is continuously circulated and renewed via a vertical unidirectional speed-regulated airflow. Combining both these techniques eliminates the particles present in the enclosure and provides protection against external contamination.
"By avoiding confinement, the continuous air circulation extends aseptic state time and provides up to 72 hours of production without having to stop fordecontamination," Serac stated.
The sterile area is surrounded by barrier zones that are also subjected to unidirectional airflow.These act like an additional protective envelope between the enclosure and the rest of the workshop and make cleaning and maintenance operations on the machineeasier, Serac stated.
The heart of the machine is a sterile enclosure that can only be accessed in production via glove boxes that are placed at critical locations along the filling line.
All the other points - treatment, line input, and output - can be reached via external doors without having to wearclean room clothing. All accesses into and out of the barrier zone are monitored and recorded soprocessors can track operations.
Serac developed its new RABS isolator by drawing developments in the pharmaceutical industry.
Serac specialises in manufacturing filling and capping machines for liquid and semi-liquid products along with complete packaging lines.