A comprehensive range of Restricted Access Barrier Systems for aseptic processes.
Designed for pharmaceutical classified cleanrooms.
Tema Sinergie RABs Series is developed to meet all applicable requirements for aseptic processing. From small to large batch production systems, 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. Tema Sinergie offers different kinds of custom-designed barrier systems by directly managing the integration activities with a party machine manufacturer and the end user.
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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.
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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.
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Closed RABs: a positive pressure 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 Bio-decontamination system to provide with a cGMP class A/ISO 5 environment.
Applications
Typical application: Filling processes
Compliances
Annex 1, EU Guidelines, cGMP, GAMP 5, FDA CFR 21 Part 11.
