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. 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 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
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.
