Tema Sinergie

Restricted Access Barrier Systems (RABS)

Restricted Access Barrier Systems (RABS) provide superior product protection to traditional systems, and offer a viable alternative to Isolators and cleanrooms.    
Our equipments are designed to meet all existing requirements for aseptic processing.

RABS provide 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 develops different kind of RABS:

  • Open Passive RABS: barrier system which utilises 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 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 VPHP bio-decontamination system to provide with a GMP Class A ISO 5 enviroment.

All systems are designed to create a physical barrier to separate the process from the operator.

 

General characteristics

  • Main shell structure made of high-grade stainless steel AISI 316L
  • Sheathings and support structure made of stainless steel AISI 304
  • Mirror Brite internal finishing (<0,3 µm), and Scotch Brite external finishing (<0,8 µm)
  • Weldings ground, smoothed and polished

Key features

  • Easily connectable to any gaseous H2O2 generator available on the worldwide market
  • Integrated gaseous H2O2distribution circuit
  • Gaseous H2O2resistant anemometer
  • Gaseous H2O2resistant relative humidity and temperature (rH%+T) sensor
  • Handle with integrated safety switch
  • LED lighting system

 

  • SIMATIC HMI TP700 Comfort Siemens, 7” Touch Panel with TFT colour widescreen display
  • PLC Siemens S7
  • GAMP compliant software development
  • VPN connection for remote access and assistance, updates and maintenance

PLC-controlled barrier systems, 21 CFR part 11 compliant, fitted with a friendly operator interface available in different languages.

Our RABS are also fitted with a Virtual Private Network connection, which allows a secure and private communication via Internet network, and provides remote access and assistance, updates and maintenance any time, everywhere.