Modular-Lab PharmTracer is your solution for efficient routine production of radiopharmaceuticals and research. It uses disposable cassettes containing all the necessary components for a particular synthesis. The cassettes are assembled under GMP-compliant clean room conditions, sterilized with gamma-radiation and double vacuum packed. All consumables used are chemical resistant and have been tested for their suitability with the specific syntheses. By customizing the synthesis cassettes and adapting the projects in the software new tracers and processes can easily be developed.
The laboratory equipment Modular-Lab PharmTracer has been specifically designed to allow versatile and efficient routine production of different tracers, complying with GMP requirements. The concept of disposable cassettes enables the user to easily label different radionuclides with the same setup, but without the risk of cross contamination.
The system retains the reliability and versatility of the Modular-Lab Standard system, allowing to make changes in the process as necessary during early-stage development, but then “lock-in” the process for routine production. With this addition, Modular-Lab PharmTracer is the ideal platform for development as well as production of radiopharmaceuticals.
The Modular-Lab PharmTracer setup for the labeling of 68Ga-, 111In-, 177Lu- and 90Y-DOTA peptides will be combined with a Heater Reaction Module (HRM), a Syringe Module (SYM) and, if necessary, with an additional 1-fold Module (SLM-1) when performing the a presure test before the synthesis. Sterile disposable cassettes ensure easy handling by click‘n’start technology. The easy-to-program intuitive graphical interface of the Modular-Lab software is used to control or adapt the synthesis process.
Sterile Disposable Cassettes
All cassettes are assembled under GMP-compliant clean room conditions, sterilized with gamma-radiation and double-vacuum-packed. The consumables used are chemical resistant and have been tested for their suitability with the specific syntheses. A shelf life of 18 months can be guaranteed. Cartridges are included and preconditioned automatically if necessary. Due to the cassettes one-time use no cleaning, drying or sanitation routines are necessary.
Modular-Lab PharmTracer is based on a unique, modular approach combining the speed and safety of a remote, fully-automated system with the option to configure syntheses for novel tracers. The GMP-manufactured sterile disposable cassettes avoid intense cleaning and sanitation routines. The synthesis process is programmed by Eckert & Ziegler Eurotope making additional programming dispensable. Modular-Lab PharmTracer’s multifunctionality supports routine production of 68Ga-, 111In-, 177Lu- and 90Y-DOTA peptides. The setup can also be combined with an analytical HPLC and TLC. The intuitive user interface complies with GMP, cGMP, GLP and GAMP 5 requirements. Parameters such as temperature, activity detector readings, flow rates, or valve settings can be monitored easily in one window. Reports containing all relevant data and information are created automatically after each run. In addition, a cost and space efficient alternative to the conventional electrical cabinet (EC) is now available for specific systems with low power consumption. It consists of the EC mini in combination with the software Modular-Lab SoftPLC.
Apart from this versatile system, Eckert & Ziegler also offers alternatives from the Modular-Lab family. Modular-Lab Standard uses a tubing-based approach and has been specifically designed for research and development of radiotracers, whereas Modular-Lab eazy provides a space and cost efficient solution for cassette-based routine production of Theranostics tracers.