Modular-Lab Analytical Equipment For analytical HPLC of radioactive substances Modular-Lab Standard and Modular-Lab PharmTracer provide the ideal platform for the research and production of radioactive substances. The extension of these systems with the Modular-Lab analytical HPLC Module makes the quality control of the produced agents possible with the same control unit using the same software. Description The laboratory equipment Modular-Lab Standard and Modular-Lab PharmTracer have been specifically designed to allow the production of a variety of radiotracers. Nevertheless the quality control of the products has to be performed on other equipment that has to be tested, qualified and validated for each application. Existing systems can instead be upgraded with the Modular-Lab analytical HPLC Module. The analysis by HPLC separation and detection of activity and UV-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 its own control unit and PC the analytical HPLC Module can also be used independently from the synthesis system as a stand-alone device. 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 HPLC analysis. 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 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. The system will be installed and tested with the application intended. Operators will be 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 multifunctionality of the system allows routine analysis for PET tracers based on positron emitting nuclides as well as beta emitting nuclides. For many tracers a ready-to-go operating routine is available, but customized solutions for your analytical problems can be developed as well. Software The Modular-Lab Software has an intuitive user interface, is easy to program and adhering to today’s regulatory requirements. Parameters such as pressure, activity detector readings, flow rates, UV-absorption or other parameters can be monitored within the interface. Reports containing all relevant data and information are generated automatically after each run. Quality Management Eckert & Ziegler Eurotope GmbH works with a Quality Management System according to DIN EN ISO 9001 standard. Advantages 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. HPLC Batch Report

odular-Lab Analytical Equipment Technical Data Eckert & Ziegler Your contact in USA & Canada: Eurotope GmbH Eckert & Ziegler Radiopharma, Inc. 25 Upton Drive Wilmington, MA 01887 USA Robert-Rossle-Strasse 10 13125 Berlin Germany [email protected] [email protected]