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.
Barrier isolation Technology, for aseptic and containment processes, are equipment that set a physical barrier between an operator and a work process, allowing to better handle special environmental requirements with respect to standard cleanrooms.
ATMP, cell culture manipulation, aseptic processes, HPAPI handling, sterility testing, product transfer in controlled environments, and glove integrity testing on isolators and RABS are just a few of the applications we have offered to the global market over the years.
The current pharmaceutical manufacturing procedures are subject to Food and Drug Administration (FDA) or Europe, Middle East and Africa (EMEA) regulatory guidelines, focusing on product sterility assurance as well as on understanding the safety and health needs for operator and environment protection defined under Control of Substances Hazardous to Health (COSHH) and Occupational Safety and Health Act (OSHA).
Our technological leadership in the field of Barrier isolation Technology is based on a combination of multiple factors. It began with a pioneering experience in the design and production of shielded isolators for the handling of injectable radiopharmaceuticals. Over the years, we have developed a highly specialized expertise in developing solutions for the pharmaceutical market, ensuring compliance with the most strict industry regulations.
People are our true added value. We rely on a multidisciplinary team of highly experienced designers, sales engineers, project managers, product specialists, quality control specialists, technicians, and engineers. Our expertise makes us your ideal partner to take care of your whole project, from:
