The Installation of a P.E.T. Pharmacy at
Washington University
G. Gaehle, S. Schwarz, M. Mueller, B. Margenau and M.J. Welch
Mallinckrodt Institute of Radiology, Washington University Medical
Center, 510 S. Kingshighway, St. Louis Missouri 63110
Abstract
Washington University has produced radioisotopes for medical application since the early 1960s. In order
to serve seven PET scanners and to meet more stringent government regulations we have installed a new
PET pharmacy based on our past years of experiences. The new pharmacy was installed at the site of the
3.7 MeV tandem cascade accelerator that was decommissioned in April of 2001. The pharmacy consists of
a production lab, quality control lab, reagent preparation lab, shipping and storage area and an office.
Security and safety was a main consideration in the design of this PET pharmacy.
the cyclotron occurred on 01/01/2002,
results are shown in table 1.
A self shielded CTI RDS111 cyclotron was
18
installed to supply the following precursors, F-
F-fluorine, 11C-carbon dioxide, 11C13
carbon monoxide,
N-ammonia, 15O-oxygen,
15
O-carbon dioxide and 15O-carbon monoxide.
15
O -oxygen, carbon monoxide and 15O-water
Fluoride,
18
Table 1
Date
Target Material µA
/ Isotope
EOB
Minutes Form
mCi
10/01 H2 18O
40 60 18F-(H2
1218
18
O)
18
10/02 H2 O
40 60 18F-(H2
1310
18
O)
*
H2 18O
40 60 18F-(H2
2519
18
10/15
O)
10/17 5mM
EtOH/ 40 10 13NH4/ H2O 146
H2 O
10/17 2.5%O2 / N2
40 40 11CO2 (N2) 1532
10/25 0.5%O2 / 15N2 40 10 15O2 (N2) 1831
10/25 0.5%O2 / 15N2 40 10 C15O2 (N2) 1225
11/06 [18O]O2 98%
524
30 40 18F2
5%
F2/Ar
(5%F2/Ar)
(passivation)
11/07 2.5% O2 / N2 40 20 11CO (N2) 785
*Dual Bombardment
can be shipped to three different PET suites up
to
2500
ft
away.
To monitor radiation in personnel areas and
releases from exhaust system, a Rotem
Industries MEDI-SMART radiation monitoring
system was installed. The facility has a security
alarm with motion detectors and requires a pass
card and key for access. Cyclotron “in use” lights
are installed at both vault entrances. Two red
lights and an audible alarm are installed inside
the vault.
Installation and Acceptance
Demolition of the Tandem Cascade
accelerator site began June 11th 2001
to prepare for the installation of a CTI
RDS111.
To fully use the isotope
production capacity of the RDS111,
eight minicells BBS2 and one general
hot cell MIP-1 purchased from
Comecer (Sri, Bolognese, Italy). The
facility covers 1880 square feet. The
vault measuring 13’6” x 28’ was
originally designed for the Tandem
Cascade accelerator.
The vault
dimensions required a non standard
install of the RDS111 power supplies
and Target support units. Installation
of the RDS11 began 9/10/2001. F-18
fluoride was first produced 10/2/2001.
All target system tests were completed
on 11/07/2001. Final acceptance of
Pharmaceutical Production
The P.E.T pharmacy primary objective
is to supply 18F-Fluorodeoxyglucose
(FDG) and 15O-water, 15O-oxygen, and
15
O-carbon monoxide. The pharmacy
11
Ccan
also
supply
various
13
Nradiopharmaceuticals
and
ammonia.
To produce 18F-Fluorodeoxyglucose
two different FDG modules are in use
at this facility the QuadRx from CTI
and the FDG coincidence module. The
Coincidence module has been used to
produce FDG at Washington University
since the summer of 1999. The
average synthesis time is 27 minutes
CP680, Application of Accelerators in Research and Industry: 17th Int'l. Conference, edited by J. L. Duggan and I. L. Morgan
© 2003 American Institute of Physics 0-7354-0149-7/03/$20.00
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with greater than 60% decay corrected
yield. The QuadRx was added as part
of the pharmacy installation. This
module has an average synthesis time
of 37 minutes with a greater than 50%
decay corrected yield. The QuadRx
synthesis time is longer with a
marginally lower yield than the
coincidence module, but offers the
advantage of being able to perform
four runs with a single setup. Both
modules are used weekly to produce
FDG with a greater than 95% success
rate.
**Having two modules has
enabled us to deliver FDG 100% of the
time with less than a 2 hr delay from
schedule delivery.
depending on the delivery distance to
the PET suite. At the PET suite a
Primealert (Biodex) radiation detector
signals the activation of a 3-way valve
turning off the vacuum and directing
the gas to the gas cart for inhalation
or CTI water module depending on
user selection.
15
O-water is produced in the PET suite
from 15O-oxygen using a CTI water
module.
11
C-acetate is produced routinely at
the PET pharmacy using the CTI
Grignard module that can also produce
11
C-methly iodide. The synthesis 11Cacetate takes ten minutes typically
producing 180 to 200mCi with a 20
minute, 40µA bombardment.
15
O-water, 15O-oxygen and 15O-carbon
monoxide can be shipped to three PET
suites at Washington University up to
2500 feet from the cyclotron.
CTI
developed a custom 15O-gas delivery
system for the RDS111 which has
been integrated into the long distance
15
O-gas delivery system developed at
Washington University.
This entire
system enables the RDS111 to supply
15
O-gases and water to our three PET
suites. The O-15 gas delivery system
is depicted in schematic 1.
A 11C-Methylation module designed to
produce 11C-Methionine was also
purchased from CTI. At Washington
University we will be attempting to
adapt this module to produce 11Craclopride.
Safety and Security
A Rotem industries MEDI-SMART
radiation monitoring system was
installed to monitor radiation in
personnel areas and releases from
exhaust system. To monitor personnel
areas GM-42 detectors are used that
have a measuring range of 0.05mR/h1R/h with an energy range of 50keV –
1.3MeV.
The sensitivity of the
detector is 18cps/mR/hr.
Four
detectors are used in the Pharmacy to
monitor the vault, production area,
quality control lab and shipping room.
Exhaust monitoring is done by using
the combined data from a flow rate
monitor, a GM-42 and a PM-11
detector. The PM-11 detects above
390keV at rate of up to 5000cps. In
addition to the waste gas trapping
systems of the chemistry modules
radioactive releases from the new
pharmacy have been greatly reduced
from our original facility due to the
additional trapping of the filtration
Schematic 1
The RDS111 produces 15O-oxygen or
carbon monoxide and releases it into
the long distance delivery system. The
long distance delivery system is under
vacuum at this time. The target gas is
delivered for a set time of 15 seconds.
After the target gas is delivered a 3way valve activates supplying UHP
nitrogen at 45psi for a set time
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systems that are an integral part of
the Comecer hot cells.
Additional safety precautions include
cyclotron “in use” lights that are
installed at both vault entrances. Two
red lights are positioned in the vault
remain on during bombardment and
an audible alarm that sounds for 15
seconds at beam start up.
To
comply
with
Missouri
state
pharmacy regulations, the facility
requires a pass card and or key for
access and has a security alarm.
The pass card system monitors
personnel entry into the pharmacy and
the
alarm
monitors
unwanted
intrusion.
Results
The first patient dose of FDG was
produced by the pharmacy in January
of 2002. The pharmacy presently
supplies greater than 10 doses of FDG
a day. Other radiopharmaceuticals are
supplied as need by the medical
complex.
State
licensing
was
completed 10/11/2002.
1108