Restricted-access barrier system for the pharmaceutical industry C-RABS

for packaging lines

The C-RABS has the purpose to keep the crimping machine provided by others under Class A environment and laminar air flow the same time being treated a toxic product, it provides a significant level of containment in case of non-fully stoppered vial, an over-turned and broken vial. It can be classified as a passive RABS since ventilation is directly managed by the facility HVAC system. C-RABS for crimping machine Fully PLC controlled Software GAMP 5 compliant (21CFR Part 11 available upon request) Friendly operator interface (HMI) High grade stainless steel AISI 316L internally and AISI 304 externally Glove flanges (different size available) with gloves (different materials available) Integrated continuos liner Automatic valves for air flow interception. The C-RABS, from the process point of view, can be split in 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 the laminar flow is provided is equipped with hinged doors and two continuous liner systems for the rejection and sampling. All the glove flanges have sensors to detect hands insertion during operation. The exit mouse hole has a turbulent ventilation and independent air supply and return to balance pressure difference between the adjacent environments. The loading bin is placed on the back of the C-RABS, it is connected with tri-clamp to the crimping cabinet where a pneumatic cylinder actuates the door to let the crimps falling down by gravity into the bowl feeder.