As people are the greatest source of contamination during aseptic manufacturing of drugs, reducing personnel interventions into the process zone has a significant impact.
Our proficiency extends to all fields that require particular attention to asepsis during filling processes for both non-toxic sterile and cytotoxic products which require totally enclosed environments.
Specific equipment can be also supplied along with the barrier system, such as Preparation Isolator Systems, Unidirectional Airflow carts, Active Bio-decon Pass Through Chambers, Sterility Testing Isolators to perform all the process steps.
Our equipment are designed to meet all existing requirements for aseptic processing. A RABS provides protection by delivering a physical and aerodynamic barrier over a critical process zone with easier access to the process in the event a human intervention is required.
Tema Sinergie can develop different kinds of RABS.
Open Passive RABS: barrier system which utilizes existing cleanroom overhead air supply systems to deliver HEPA filtered air over a critical process before returning air back into the clean room.
Open Active RABS: barrier system which has an integrated ventilation system to supply HEPA filtered air over a critical process before returning air back into the clean room.
Closed RABS: a positive pressure barrier system which has an integrated ventilation system to supply HEPA filtered air over a critical process, which can pass through return filters before being recirculated. Closed RABS can also be integrated with a Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system to provide with a fully CGMP class A/ISO 5 environment.