Tema Sinergie ATMP Series is a comprehensive range of cGMP compliant isolators dedicated to production and manipulation of Advanced Therapy Medical Products for medical treatments and research purposes.
cGMP Class A/ISO 5 isolator systems specifically designed to provide the users with an environment which is safer than traditional biosafety cabinets and standard cleanrooms, by eliminating any risk from contamination of cell cultures. ATMP Series are equipped with Unidirectional Air Flow, and Integrated biodecontamination system to allow 6-log bacterial reduction.
Full integration of specific process equipment, for example incubators, digital microscope, and centrifuge.
Typical applications: autologous therapy activity processes, activation and transduction process of non-infectious viruses, viral vectors, allogeneic therapy activity processes, Gene Therapy processes.
Compliances: Annex 1, EU Guidelines, cGMP, GAMP 5, FDA CFR 21 Part 11.