GE Healthcare

FASTlab
*
FDG cassette with integrated reagents phosphate formulation
Data Sheet
Application
The application for production of 2-deoxy-2- [
18
F] uoro-D-glucose
([
18
F]FDG), the most widely used PET compound is supplied as
standard with FASTlab equipment.
[
18
F] Fluoride is produced by a cyclotron (for example GE PETtrace
*

or MINItrace
*
) and converted into [
18
F] FDG in less than 23 min.
FASTlab is designed to operate within pharmaceutical
manufacturing operations and to produce [
18
F] FDG with a
composition consistent with USP and Ph Eur monographs.
High-yield independent of starting activity (74% uncorrected yield
tested up to 19Ci starting activity) with high reproducibility (>98%)
is achieved through ne-tuned synthesis parameters, optimized
cassette and system design.
Features
Integrated cassettes loaded with reagents and mannose trifate
precursor.
Cassettes supplied by GE Healthcare are manufactured in a
controlled environment and include reagents manufactured
under cGMP standards with precise quantities and formulations.
They are accompanied by a Certicate of Analysis.
Cassettes supplied by GE Healthcare are tested for bioburden.
Cassettes are marked with a barcode for automatic
identication and recovery of batch information. The barcode
also ensures that the optimal synthesis parameters for [
18
F] FDG
are automatically loaded.
All parts and components in contact with the chemicals are
replaced at every run ensuring clean operation.
DMF type II describing the tracer application has been fled to
the FDA. Letter of references to the DMF as well as other
regulatory support documentation are available upon request.
FDG chemical process phosphate formulation
The mannose triate precursor is labelled following the
nucleophilic substitution method in presence of Kryptox
*
.
The resulting tetra-acetyl-
18
F-glucose is trapped on a standard
reverse phase extraction cartridge and a preliminary purication
of the intermediate compound is performed. The acetyl groups
are hydrolysed in less than two 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 (phosphate buffer), puried and sterile
ltered. The tracer is then ready for dispensing and quality
control. The [
18
F] FDG produced is specially formulated to allow
terminal sterilization by the autoclave if desired.
Cassette supplies
Cassettes (to be used on S9170AA FASTlab multitracer platform)
are supplied with all the components and reagents needed for
the production of human-use [
18
F] FDG (except enriched water).
P5370JD FASTlab FDG cassette pack integrated with reagents
P5370KF FASTlab product collection accessories including
a sterile product collection vial, a sterile product lter, a
sterile vent lter and 2 sterile needles
Shelf life = 18 months
Storage condition: room temperature
For other tracer applications developed on FASTlab, other
packages are available.
Note:
The use of such cassettes to produce [
18
F] FDG for injection to human bodies is the
sole responsibility of the user. GEHC is not liable for any adverse effect that might
occur during or after such use.
System performance for FDG phosphate synthesis
Technical data
Cassette set up time <60 sec
Synthesis time <23 min
Typical
1
average production
yield, decay uncorrected
2,3

74% 4
4
Typical
1
average
radiochemical yield, decay
corrected
2, 3
85% 4
4
Cassette removal time <30 sec
Residual activity on cassettes
at end of synthesis
4

<0.8% EOB
Additional specications
Radiochemical purity >98%
Residual acetonitrile
5
<Most stringent standard
Residual organic solvents
5
<Most stringent standard
Residual phase transfer
5
<Most stringent standard
pH
1
4.5 6.3
FDG nal volume 15 ml 0,5
Bioburden <100 CFU/cassette
Warranty
GE Healthcare provides specic warranties with respect to
the products described. The applicable written warranties for
these products are available upon request. Rights reserved to
make changes.
1
These are typical performance parameters and can vary depending on site
set up and the measurement methods used.
2
Lower specifcation limit on yield for individual runs, decay uncorrected: 60%.
3
Independent of starting activity level (up to 19Ci of starting activity).
4
After automatic cassette cleaning cycle.
5
USP or Ph Eur.
GE Healthcare
3000 North Grandview Blvd
Waukesha, WI 53188
U.S.A.
www.gehealthcare.com
2011 General Electric Company All rights reserved.
General Electric Company reserves the right to make changes in specifcations and
features shown herein, or discontinue the product described at any time without notice
or obligation. Contact your GE Representative for the most current information.
GE, GE Monogram and imagination at work are trademarks of General Electric Company.
GE Healthcare, a division of General Electric Company.
* Trademark of General Electric Company.

Kryptofx is a trademark of Merck KGAA.

RDPH-0129-06.11-EN-US