Modular-Lab HPLC System
The laboratory equipment Modular-Lab Standard and Modular-Lab PharmTracer have been specifically designed to allow the production of a variety of radiotracers. The quality control of the products had to be performed on other equipment that had to be tested, qualified and validated for each application. With the new Modular-Lab analytical HPLC Module the analysis by HPLC separation and detection of activity, UV- and RI-signal allows this part of the quality control to be performed on the Modular-Lab platform technology with the same control unit, PC and software as the synthesizer.
With an own control unit and PC the analytical HPLC Module can also be used independently (stand-alone device) of the synthesis system. The system is easy to operate. Pre-validated processes are available for many applications or can be freely programmed by the user. The system performs isocratic HPLC elution. A second pump allows a gradient HPLC 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 pump K120 (second for gradient), a Knauer UV detector smartline UV 2520, a Knauer HPLC Online-Degasser, a HPLC-column and all tubing and connectors as well as a control unit. The system will be installed and tested with the application intended. The operators will be trained and optional an on-site performance qualification of a defined analytical process can be done. For the evaluation of the data a software tool for background-correction, peak analysis, fitting and comparison is available. Data are compiled into tables and a report can be generated.