Barrier Systems for Every Pharmaceutical Process
Tema Sinergie develops custom RABS systems tailored to the specific requirements of the process to be protected, managing every step directly: from preliminary audits to design, sizing, and integration with third-party suppliers.
Each solution is engineered to meet the highest aseptic standards, ensuring ease of cleaning, accessibility, and ergonomics, in full compliance with the most stringent cGMP regulations (Grade A, ISO 5, in Grade B, ISO 7 environments) and major international guidelines. Fully compatible with retrofitting projects on existing facilities.
COMPATIBLE WITH NEW AGLTS 2
All RABS systems developed by Tema Sinergie provide stringent and effective protection for the entire pharmaceutical manufacturing process, dramatically reducing the risk of contamination due to human intervention.
To ensure maximum safety, Tema Sinergie performs an in-depth analysis of the process characteristics and potential criticalities, in order to implement targeted engineering solutions and design systems that maximize production flow reliability.
Every Tema Sinergie RABS system is a fully customized project. Elements such as ventilation, glass surfaces, and localized air intakes are optimized according to the specific process.
Thanks to an integrated approach and in-depth knowledge of aseptic processes, Tema Sinergie designs a wide range of RABS systems, meeting all current requirements for aseptic manufacturing.
Open RABS (O-RABS)
O-RABS systems feature a direct connection with the surrounding environment. The air flowing through the sterile process area is exhausted directly into the cleanroom.
If equipped with its own ventilation system — including fans, filters, and control units — it is classified as active. If it relies solely on the room’s ventilation system, it is defined as passive.
Closed RABS (C-RABS)
C-RABS systems provide a higher level of protection than O-RABS thanks to a fully enclosed configuration, even though they are not sealed systems.
Air inside a C-RABS is recirculated through its own ventilation system, allowing for more precise and secure airflow control within the process environment.
Tema Sinergie’s RABS systems offer maximum configuration flexibility and custom technical solutions, ensuring seamless integration with any plant or cleanroom.
Optimizing operator workflow is essential to minimize accident risk, reduce unplanned downtime, and uphold high production quality standards. Ergonomic design ensures a safe and comfortable working environment.
Through a secure VPN connection, remote access, troubleshooting, software updates, and maintenance interventions can be carried out anytime, anywhere.
Low-voltage fans designed with sustainability in mind allow the isolator to maintain low energy consumption throughout its operational life.
I sistemi RABS possono essere equipaggiati con un Sistema integrato di Test Guanti Automatico (AGLTS 2), conforme allo standard internazionale ISO 14644-7 Annex E.5 e alle nuove disposizioni dell’Annex 1, EU Guidelines.
Key Features
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RABS systems are controlled by a Siemens S7-1500 PLC and a 12” SIMATIC HMI panel, featuring touchscreen TFT widescreen display and user-friendly graphics.
The operator interface, developed by Tema Sinergie, enables simple and intuitive use, including a “one-touch” function and access to saved work programs.
The control software is fully compliant with GAMP5 and FDA 21 CFR Part 11 requirements.
