Tema Sinergie is a technological benchmark for the production of customized barrier isolation technology systems designed for the global pharmaceutical market.
We specialize in the design and manufacture of aseptic isolation and containment technologies to address the requirements of pharmaceutical and biotech companies, as well as industrial partners implementing large automated production lines.
Tema Sinergie is bringing the most innovative solutions to the pharmaceutical sector! Come and witness ZEROC, AGLTS 2, and CST-IS— cutting-edge technology at its finest!
Automatic integrity tester for Alpha and Beta Rapid Transfer Systems (RTP)
ZEROC is the new RTP tester developed to perform a complete integrity test on Rapid Transfer Ports (Alpha part), installed on isolators or RABS, and their containers (Beta part) in a fully automatic way.
It’s an extremely versatile system that guarantees an accurate and repeatable test based on the pressure decay method. It can be used for both aseptic and containment processes, offering the same highest reliability.
Automatic Glove Leak Tester
AGLTS 2 is the brand new fully automatic GMP compliant Glove Leak Tester for Pharmaceutical Isolators and RABS in the pharmaceutical industry, developed referring to the Positive Pressure Decay Method which follows the international standard ISO 14644-7 Annex E.5.
A new generation device way beyond the mere execution of glove testing, supporting the operators and pharmaceutical companies in the management of all glove testing related operations.
Compact Sterility Testing Isolator System
The Compact Sterility Testing Isolator System (CST-IS) is a modular cGMP Class A/ISO 5 isolator system specifically designed for QC Laboratories.
The system is designed to deliver the best aseptic performance even in confined spaces: in just 2.5 meters, it houses a process chamber, complete with an integrated peristaltic pump, connected to a transfer chamber and an integrated VPHP bio-decontamination system.
Tema Sinergie develops solutions with a strong focus on the specific process, prioritizing user comfort for daily operations. Since the very initial pre-sales stages, our technical sales team closely collaborates with the customer, providing dedicated engineering consultancy and defining the broad specifications of the application.
Isolator design is constantly being enhanced, thanks to ongoing dialogue with our customers. Continuous and calculated research of high quality materials and components guarantees our solutions a high level of quality and safety. Our barrier systems are designed for global installation, manufactured in strict accordance with regulations set forth by the U.S.
Food and Drug Administration (FDA) and equivalent bodies in Europe, the Middle East, and Africa (EMEA).
+ Equipment Integration
We strive to integrate our products with the equipment and accessories required for specific processes. We manage integration activity directly with third-party companies, guaranteeing a final result of the highest quality standard.
+ Ergonomic Design
All Tema Sinergie isolators are conceived and designed to be operator-friendly, in accordance with the international principles of human ergonomics. Customer needs are a key part of our design process. Our primary goal is to enhance user operability to minimize the risk of accidents and eliminate downtime.
+ From idea to prototype
We develop full-scale mock-ups to test required ergonomic and customizations, optimizing the design process and preventing time-consuming adjustments during production.
Professionalism, proactivity, passion and business intelligence are features that distinguish us every day since 1985. These qualities allow us to become a reliable partner. We are a multidisciplinary, dynamic and innovative group of people, focusing on our mission: promoting a better quality of life.
We closely collaborate with our customers, providing our expertise to deliver the most suitable solutions to meet their specific needs. Our wide range of services aims to improve the quality and safety of the operators. We are organized in multidisciplinary dedicated teams that work closely together on a daily basis. Continuous sharing of internal knowledge allows our business units to enhance their know-how.
