more than 25 years of experience in development of process control
and chromatography software,
high flexibility in hard- and software,
regulatory compliance and
radiochemistry process know how.
The name SynChrom is derived from the combination of "Synthesis & Chromatography"
within one instrument.
raytest has developed 5 different SynChrom units, all based on the same
hardware platform:
18F-FDG,
F2 (electrophilic substitution),
R&D (nucleophilic substitution),
11C and
MPI (Multi Purpose Interface).
All SynChrom units have been designed to be very compact, fully integrated and
flexible.
The built-in synthesis module requires a minimum of cable connections to
the outside of the hot cell.
This structure also allows remote support via VPN.
All wetted instrument parts such as valves and tubing are resistant against reagents
and solvents.
All SynChrom units are using mainly the same, fully tested and long term reliable
compounds.
The modular design allows easy and fast handling and maintenance.
All instruments consist of 3 main areas:
The front area contains most often used parts like precursor and solvent containers,
tubings, reaction vessel and gas connectors.
The inside area contains rarely used parts such as pressure sensors, radiation
detectors and the vacuum pump. Direct and easy access to these parts is given by
lifting up the front door.
The electronics which are never touched by the user are housed in the back area.
All units are easily upgradable by the user (valves, tubings, detectors etc. / the
systems are equipped with several free available control outputs and inputs.).
The low dead volume magnetic flipper valves are pressure tight up to 4 bar.
All units contain an ultra low noise, ultra low pressure, double membrane, solvent
resistant vacuum pump for pressures down to 40 mbar and a special glass liquid
nitrogen cold trap for drying and protection of the environment and the vacuum pump.
Shielded radiation detectors are built-in to observe, analyze and document the
synthesis run.
The reaction vessel is made of a specially designed Duran glass and is available
with volumes from 8 ml to 18 ml, dependant on the synthesis process.
In combination with the reactor vessel form the reactor allows very fast temperature
changes of the reaction solvent.
The displayed temperature is the real temperature in the solvent.
The F2 reactor is cooled by liquid nitrogen and can be operated in the temperature
range of - 60 °C up to 200 °C .
The R&D and FDG reactors are cooled by compressed air and are working in the
range of +20 °C up to 200 °C.
An infrared liquid detector reliably detects the solvent level after transportation
out of the reactor to the purification step.
All units are equipped with a cleaning procedure and pressure test procedure.
The SynChrom units are controlled by the raytest software GINA Star.
GINA Star software is also used for the following quality control procedure, thus
using only one software package for all applications in the PET lab.
GINA Star can be operated either in the full flexible R&D mode or in the
GLP/GMP - 21 CFR Part 11 mode.
In R&D mode the user can generate his own tubing drawing, valve connections
and interactive timetables or he can modify existing unprotected processes.
In the regulatory compliant GLP/GMP - 21 CFR Part 11 mode the user can operate the
system with predefined processes and configurations. Data and synthesis process are protected against intentional and unintentional manipulations.
The start of the synthesis procedure can be triggered by the cyclotron or by the
SynChrom input detector.
During the run the user can observe the status of the synthesis process visualized
by the drawing schematic as well as in the timetable.
Manual interactions during the synthesis run are possible and are recorded and
reported automatically.
GINA Star SynChrom combines full flexibility, easy handling, full documentation and
regulatory compliance.
Never before it was easier to generate and modify a synthesis process or just
execute a predefined procedure.
Compounds pictures:
Peek reaction vessel cap
Reactor parts
Magnetic flipper
Solvent container
Reaction vessels, product vessel & water recovery vial
