France, Paris - Fax : +33 (0)1 30 70 98 55

Product Data
April-2007 rev C A4 format TRACERlab MX
FDG

S9140 JA / JB

Japan, Tokyo - Fax: +81 3 3223 8524
Singapore - Fax: +65 291 7006
USA, Milwaukee - Fax: +1 262 521 6123

GE Healthcare
Chalfont St. Giles,
Buckinghamshire, UK
www.gehealthcare.com
Application
The TRACERlab MXFDG is a compact
automated radiochemistry for easy and
efficient production of 2-deoxy-2-
[
18
F]fluoro-D-glucose ([
18
F]-FDG), the
most common tracer for PET
examinations. [
18
F]Fluoride produced by
a cyclotron (for example PETtrace and
MINItrace) is injected into the system
and converted into [
18
F]FDG
in less than 25 min.
Features
This easy-to-use system synthesizes
high quality [
18
F]-FDG with high output,
using disposable cassettes.
High and reproducible yields
TRACERlab MXFDG synthesis module
No laboratory preparation before and
no cleaning after production
System based on use of sterilized
disposable cassette: meets
pharmaceutical standards and
prevents cross contamination
Back to back production capability
High and proven uptime
User-friendly real time graphical
interface, automated record keeping
compliant with GMP
Ready-for-use reagent set available
Automatic recovery of enriched water
Built-in activity detectors
Disposable Cassette Design for GMP
compliance and maximized uptime
Due to the sterilized cassette concept,
the TRACERlab MX allows
reproducible and back-to-back
synthesis operation, and meets GMP
compliance/standards. Certified ready-
for-use reagent sets are available,
packed in color-coded vials to facilitate
error free set-up. All parts and
components in contact with the
chemicals belong to the cassette and
are replaced at every run. This prevents
any possible cross contamination
between production runs, ensures
reproducible yields, provides clean
operation conditions and maximizes
uptime.
FDG
Easy Operation
Preparation time is minimized and no
cleaning procedure is required at any
time.
The system is easy to operate and would
not require specific chemistry skill when
used with ready-of-use reagents sets.
After self-diagnosis, the synthesis can
start upon request when the
18
F activity
has been transferred to the synthesizer.
The progress of the synthesis can be
tracked on the interface computer.
Conditioning of C18 cartridges and
dissolution of the dry mannose triflate in
the appropriate amount of acetonitrile
are performed automatically during the
synthesis.
To meet GMP requirements, TRACERlab
MX provides concise real-time view of
synthesis parameters, such as
radioactivity in four selected locations,
temperature and pressure.
FDG
A report is generated at the end of the
each run including main measurements,
synthesis identification and quality
control.
The operator is informed when the [
18
F]-
FDG is ready. The [
18
F]-FDG solution is
neutral, isotonic and ready
for injection after appropriate QC.
After synthesis, nearly all-residual
activity (less than 5% remaining) is
automatically drained away into an
external shielded container.
After removing the kit (in about 10
seconds), the system is available for the
next run.
User-friendly Graphical Interface and
Control System
The TRACERlab MXFDG module includes a
Programmable Logical Controller (PLC)
that manages the entire operation
program stored in its internal memory.
The computer is used to assist the
operator during the preliminary steps
before synthesis, to allow visualization of
the process, to view and print the
reports, to configure the PLC and to
perform some tests for maintenance.
Research & Development user can
System performance
Technical data:
- Synthesis preparation time: < 5 min
- Synthesis time: <25 min
- Typical* average radiochemical yield, decay
uncorrected
1,2
:
60 %
- Typical* average radiochemical yield, decay
corrected
2
:
70 %
- Standard deviation: 4%
- Residual activity on cassette at end of synthesis
3
: <5% EOB
(*) These are typical performance parameters and can vary depending on site set-up and the
measurement methods used.
1
Lower specification limit on yield for individual runs, decay uncorrected: 50%
2
Independent of starting activity level (up to 10Ci of starting activity)
3
After cassette automatic cleaning cycle

Additional features:
- Radiochemical purity: > 99.5 % , no
18
F-FDM (**)
- Residual acetonitrile: Typically < 0.05 mg/ml
- Residual ethanol: Typically < 0.4 mg/ml
- Residual Kryptofix: < 0.01 mg/ml (below detection limit)
- pH: 6.4 0.5
- Osmolality: 290 30 mOsm/Kg (isotonic)
- Amount of [
18
F]-FDG solution: Typically 16 0.5 ml
(**) Refer to Applied Radiation and Isotopes 56 (2002) 871-875
Copyright GE Healthcare Page 1


France, Paris - Fax : +33 (0)1 30 70 98 55


Product Data
April-2007 rev C A4 format TRACERlab MX
FDG

S9140 JA / JB

Japan, Tokyo - Fax: +81 3 3223 8524
Singapore - Fax: +65 291 7006
USA, Milwaukee - Fax: +1 262 521 6123

GE Healthcare
Chalfont St. Giles,
Buckinghamshire, UK
www.gehealthcare.com
customize or create new sequences for
similar nucleophilic fluorinations.
The production process itself of [
18
F]-
FDG is defined in a fixed program with
pre-set optimised parameters, which is
protected in order to minimize the risk of
unauthorized customisation or changes.
Chemical process
The mannose triflate precursor is
labelled following the nucleophilic
substitution method in presence of
Kryptofix. The resulting tetra-acetyl-
18
F-glucose is trapped on a standard
reverse phase extraction cartridge and a
preliminary purification of the
intermediate compound is performed.
The acetyl groups are hydrolyzed in less
than 2 minutes within the cartridge, at
room temperature, in presence of
sodium hydroxide.
The [
18
F]-FDG is collected with a small
amount of water, then neutralized and
buffered, purified and sterile filtered.
System Specifications
The system is self-contained. Process
control unit is built-in the synthesis
module
Size: 56x36x42 cm (LxWxH)
Weight: 48 kg
For a detailed description of required
supplies please refer Installation Guide.
Environmental requirements
For efficient tracer production, the
TRACERlab MXFDG should be housed in a
suitable vented shielded cell providing
appropriate shielding, according to all
applicable radioprotection laws.
GE can deliver a shield designed for the
Process Module on request
Voltage:
115 Vac/50 or 60 Hz (S9140JB)
230 VAC/50 or 60 Hz (S9140JA)
Power consumption: <300W
Compressed air: 6-8 Bar
Nitrogen: 2-10 Bar
The system is CE marked.
System components
The system includes the following parts
necessary for installation, start-up and
acceptance, except application training,
consumables and chemicals, which has
to be ordered separately.
The S9140JA/JB includes as follows:
- P5150MA/MB (230VAC/115VAC)
TRACERlab MXFDG module
- P5150MC - Laptop computer
- P5150MD - Software Package
- P5150ME - Sterilized Disposable
Cassettes for 50 runs
- P5150MF - Accessories (for 50
cassettes)
- P5150MH - Site kit
- P5150MJ - Installation kit
- User manuals


To be ordered separately
- P5150MG, TRACERlab MXFDG Chemistry
kit, for 10 test runs for acceptance test
only.
TRACERlabMXFDG Disposables
Each batch production of FDG will
require a set of chemicals and con-
sumable components. The chemicals
are provided through specialized
companies.



P5150ME, Sterilized Cassettes (50)
One cassette is used per FDG
production.
P5150MF, Accessories (for 50
cassettes)
These cassettes and accessories include
all the separation and purification
columns and other components needed
for the synthesis.
Required chemicals Not included in
the Delivery
The following chemicals are required for
production of FDG: Mannose triflate,
acetonitrile, sodium hydroxide, kryptofix,
potassium carbonate, sodium chloride
and sterile pyrogene free water. Ready-
for-use pharmaceutical grade reagent
sets are also commercially available.
Warranty
GE Healthcare provides specific
warranties with respect to the products
described. The applicable written
warranties for these products are
available upon request. Rights reserved
to make changes.
NOTE: Data subject to change.

Copyright GE Healthcare Page 2