For many tracers now the quality control of radiopharmaceuticals by high performance liquid chromatography analysis is available with Modular-Lab, but also customized solutions for your analytical problems can be developed. Ready-to-go routines, tested and validated are installed and with the easy-to-learn software the operators can well handle the system after the included training.
The laboratory synthesis equipment Modular-Lab has been specifically designed to allow the production of a variety of radiotracers. Nevertheless, the quality control of the products had to be performed on other equipment that had to be tested, qualified and validated for each application. Now, existing systems can be upgraded with the new Modular-Lab analytical HPLC Module. The analysis by high performance liquid chromatography separation and detection of activity and UV- signal allows this part of the quality control to be performed on one platform technology with the same control unit, PC and software as the synthesizer.
With its own control unit and PC the analytical HPLC Module can also be used independently (as stand-alone device) from the synthesis system. The system is easy to operate and pre-validated processes are available for many applications or can be freely programmed by the user.
The basic system runs isocratic analysis. A second pump allows a gradient profile. In a standard setup i.e. for the detection of radioactive labeled DOTA-conjugated peptides the analytical HPLC system consists of a HPLC Module (with injection valve, shielded activity detector, holder for column), a Knauer AZURA pump 4.1S (second for gradient), a Knauer UV detector UVD 2.1S , a Knauer HPLC Online-Degasser, a HPLC-column and all tubing and connectors as well as a control unit. All parts will be installed and tested with the application intended. The operators are trained and optionally an on-site performance qualification of a defined analytical process can be done. For evaluation of data a software tool for background-correction, peak analysis and graph fitting is available. Data are compiled into tables and a report can be generated.
The Modular-Lab analytical HPLC Module can be directly connected to any system of the Modular-Lab product family for an easy and low-cost possibility of HPLC-analysis. The analysis processes are programmed and tested by Eckert & Ziegler Eurotope GmbH. The multifunctionality of the system allows routine analysis for PET tracers based on positron emitting nuclides and also for beta emitting nuclides. For many tracer ready-to-go operating routines are available, but also customized solutions for your analytical problems can be developed.