Isolation Technology

Closed Restricted Access Barrier System for Crimping

| PRODUCT MANUFACTURER: COMECER

Product Description

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.

C-RABS Overview

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.

Main Features and Benefits

  • Used in fill finish manufacturing
  • Used for RABS & C-RABS
  • Fully PLC controlled
  • GAMP 5 compliant software (21 CFR Part 11 available upon request)
  • User friendly HMI operator interface
  • Highest grade 316L stainless steel internal components
  • Glove flanges (available in a variety of sizes)
  • Gloves available in a variety of materials
  • Integrated continuous liner
  • Automatic valves for airflow interception

Options

  • Please speak with a STEQ America team member for more information

Accessories

  • Please speak with a STEQ America team member for more information

Additional Product Model Imagery

C-RABS crimping - loading hopper

C-RABS hopper, pneumatic port

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