Tema Sinergie S.p.A. products

KARL100 is the most complete and safest Class A radiopharmaceutical dose administration system available on the international market, with 6 major benefits.

From pharma to nuclear medicine: the Radio-protection reborn; NEXT is the groundbreaking combo of a non-shielded isolator with a shielded automatic dispenser: from Pharma to Nuclear Medicine, a fully GMP-compliant aseptic process with a smart shielding solution for a cutting-edge approach to radio-protection.

The Flexa-Flexall hot cell is a turnkey system composed of a GMP grade B shielded isolator for synthesis and a GMP grade A shielded isolator for dispensing, in one single hot cell.

DHC is a GMP grade A shielded isolator, with vertical laminar flow all over the working area, dedicated to radiopharmaceuticals dispensing processes in a controlled and safe environment. DHC was first conceived to provide the most relevant radiopharmaceutical companies a total laminar flow dispensing shielded isolator compliant with the latest GMP, USP and FDA regulations.

SYNT cell has been designed to host automatic radiopharmaceutical synthesis modules, offering a controlled and safe environment in compliance with the latest GMP guidelines. Its inflatable seals are granting an ISO 10648:2 air tightness while the ventilation system provides a GMP class B clean air environment.

The SYNTHERA HC is designed to house IBA Synthera® synthesis modules in the safest conditions.

SAFEFLOW is a Class II biohazard safety cabinets with a GMP grade A laminar flow, with different shielding configurations; it is designed for the manual preparation of Nuclear Medicine radiopharmaceuticals injectable doses.