The C-RABS (Closed Restricted Access Barrier System) for crimping by Comecer, is designed to keep your crimping machine under a Class A environment and laminar airflow. Whilst treating a toxic product, it provides a significant level of containment in case of a non-fully stopped vial or overturned or broken vial. This system can be classified as a passive RABS since ventilation is directly managed by your facility’s HVAC system.
The C-RABS, from the process point of view, can be split into three sections:
- SECTION 1: Crimping Cabinet (the part housing the automatic crimping machine
- SECTION 2: Exit Mouse Hole
- SECTION 3: Crimp Loading Bin
The Crimping Cabinet, where laminar flow is provided, is equipped with hinged doors and two continuous liner systems for the rejection and sampling processes. All the glove flanges have sensors to detect hands insertion during operation.
The Exit Mouse Hole has a turbulent ventilation and independent air supply, as well as a return to balance pressure difference between the adjacent environments.
The Loading Bin is placed on the back of the C-RABS and is connected to the crimping cabinet with a tri-clamp. A pneumatic cylinder actuates the door to allow the crimps to fall down and into the bowl feeder.
GAMP 5 compliant software is completely integrated into the PC of the crimping machine so that a single HMI need only be used by the operator.