radiochemistry solutions
DESCRIPTION
Radiochemistry Solutions. Total Solution Provider Eclipse: Upgradeable cyclotrons Explora: Full line of radiochemistry modules Start up and continued support for current and future growth. Leadership in radiopharmaceuticals production. Explora FDG 4 Quality FDG production - PowerPoint PPT PresentationTRANSCRIPT
For internal use only / Copyright © Siemens AG 2006. All rights reserved.
Radiochemistry Solutions
Innovation is in our genes.
2 Siemens Healthcare Molecular Imaging
Leadership in radiopharmaceuticals production
Total Solution Provider
Eclipse: Upgradeable cyclotrons
Explora: Full line of radiochemistry modules
Start up and continued support
for current and future growth
Innovation is in our genes.
3 Siemens Healthcare Molecular Imaging
A broad range radiochemistry offering
Explora FDG4
Quality FDG production
Explora CNCyanide synthesis
Explora GPUGas processing
Explora ACProduces acetate
Explora H2O15O water module
Explora FDG4 Explora CN
Explora AC Explora H2O
Innovation is in our genes.
4 Siemens Healthcare Molecular Imaging
Explora FDG4 specifications
45 minute synthesis
75% decay corrected yield
4 runs without intervention
Novel recipe building software
Remote diagnostic capability
Automatic self-cleaning
Rich user feedback (radiation, temperature, pressure sensors)
Low cost of operation
Minimal custom parts (uses conventional disposable glassware)
Innovation is in our genes.
5 Siemens Healthcare Molecular Imaging
Explora FDG4 – Multirun synthesis moduleConvenient - Smart - Reliable
4 runs without intervention
Remote diagnostic capability
Automatic self-cleaning
Rich user feedback
(radiation, temperature, pressure sensors)
Low cost of operation
Run number Synthesis yield
Total FDG
1 81% 6760 mCi
2 77% 5520 mCi
3 78% 6440 mCi
4 69% 5070 mCi
4 runs 76% average 23790 mCi total
Daily Usage
Innovation is in our genes.
6 Siemens Healthcare Molecular Imaging
Explora convenient
4 runs without intervention Set up once, run all day Kits are available for streamlined setup Reagents are inverted on disposable spikes No measurement of reagents – All calculations are performed
automatically via software
Innovation is in our genes.
7 Siemens Healthcare Molecular Imaging
Explora smart
Everything you need to know to
optimize performance
Feedback of temperature, pressure, radiation
All data recorded for playback can see performance in trapping, labeling, hydrolysis
Synthesis data synopsis guides
performance improvement
Remote operation and test capability
Software speaks like, and understands, chemists
Innovation is in our genes.
8 Siemens Healthcare Molecular Imaging
Explora reliable
4 runs/day with > 20 Ci production yield of FDG
Has been utilized to make over 8 Ci of FDG in a single run
Has made over 150,000 batches of FDG in PETNET commercial pharmacies
40% more likely than other commercial systems to provide yields over 75%
> 99% uptime
Raw data from PETNET network records October 2004 – Mar 2008
Innovation is in our genes.
9 Siemens Healthcare Molecular Imaging
Explora summary
Reliable
Powerful
Convenient
Smart
Inexpensive
Flexible
Safe
The superior choice
Innovation is in our genes.
10 Siemens Healthcare Molecular Imaging
Explora AC – 11C Acetate module
Produces 11C acetate and other Grignard tracers.
Fully automated with high yields
Decay corrected yields >70%
Innovation is in our genes.
11 Siemens Healthcare Molecular Imaging
Explora CN – 11C Cyanide module
For producing 11C amino acid precursors
Produces high yields of 11C HCN or 11C CH4
Decay corrected yields >55%
Innovation is in our genes.
12 Siemens Healthcare Molecular Imaging
Explora H2O – 15O Water module
Provides inexpensive unit doses of 15O labeled water
Disposable cartridge
Self shielded
Simplified siting
Can be placed next to scanner bed
Innovation is in our genes.
13 Siemens Healthcare Molecular Imaging
Explora GPU – Gas processing unit
For the production of 15O and 11C gases
15O2 C15O, C15O2
11CO2 11CO
Flow chemistry
No minicells needed
Placed inside the cyclotron shields
Innovation is in our genes.
14 Siemens Healthcare Molecular Imaging
Newly introduced chemistry modules
Explora GN
For general nucleophilic reactions including FLT
Explora GPC
Methyl iodide synthesis Explora CH3
Methylation module
AND
Two new purification modules
Explora FM
Explora LC
Explora GN Explora GPC
Explora FM Explora LC
Explora CH3
Innovation is in our genes.
15 Siemens Healthcare Molecular Imaging
Explora GN –
Built on the reliability and efficiency of FDG4
Compatible with most nucleophilic solvents
Capable of delivering small reagent volumes with virtually no loss – cost benefit when using expensive precursors
Option to synthesize FDG
New software supports pressurized reaction steps
Integrates with semi-prep HPLC modules (Explora LC) and formulation module (Explora FM)
Innovation is in our genes.
16 Siemens Healthcare Molecular Imaging
Explora GN application flexibility
FDG
F-MISO
NaF
FLT
Synthesis and purification options
Seamless integration to purification modules
Innovation is in our genes.
17 Siemens Healthcare Molecular Imaging
Explora GPC – Versatile solution for methyl iodide synthesis
Key Features Flexible and completely automated
module for gas phase synthesis of 11C methyl iodide
Consistently generates high specific activity methylating agents
Capable of accepting 11C CO2 or 11C methane gas
Provides continual feedback to user via comprehensive monitoring via radiation detectors, iodine vapor density tracking, mass flow controller monitoring and feedback, pressure transducer trace and multiple temperature readouts
Concentrates and traps 11C methyl iodide and releases only when ready for subsequent steps
Capable of 15 runs between refilling / reconditioning of 11C methyl iodide
Innovation is in our genes.
18 Siemens Healthcare Molecular Imaging
Methyl iodide synthesis – the “traditional” method
Recirculating pump
Labeling furnace
Iodine furnace
Filter
Methyl iodide trap
Unintended and undesirable accumulation leading to component failure
Unintended and undesirable accumulation leading to frequent servicing
Intended accumulation leading to frequent servicing
Intended depletion leading to frequent servicing
Time for service!
Innovation is in our genes.
19 Siemens Healthcare Molecular Imaging
“Improved” methyl iodide synthesis – The Siemens method
Key advantages - Intervention into the device is minimized, thereby providing High uptime Low personnel dose Very high specific activity
Labeling furnace Reversible condenserReversible condenser
Methane in
Methyl Iodide out
Methane in
Methyl Iodide out
Innovation is in our genes.
20 Siemens Healthcare Molecular Imaging
Explora CH3 -Methylation module
Key Features
Uses solvent-based chemistry for production of 11C methylated compounds
Can be used in combination with Explora GPC
Can accept various 11C methylating intermediates in gas phase from other sources
Innovation is in our genes.
21 Siemens Healthcare Molecular Imaging
Explora FM – Formulation module
Key Features
Performs solid phase extraction (SPE) purification for final product formulation
Capable of being setup for production of 18F NaF
Flexible recipe builder software allows end user to design customer purification schemes
Innovation is in our genes.
22 Siemens Healthcare Molecular Imaging
Explora LC – Semi-prep HPLC purification module
Key Features Semi-prep or analytical radio-HPLC for
purification of crude radiopharmaceuticals
Novel loop loading method without using problematic bubble detectors
Back-to-back run capability
Automated column switching
Automated column cleaning – no manual solvent switching
Automated fraction collection via either UV signal or radiation detection
Control software complies to the guidelines specified in the 21 CFR Part 11 for the storage and protection of electronic archived data and electronic signatures.
Product includes HPLC pump, UV and radiation detector, solvent switching valve, fraction collection valve and loop loading valve with 2 loop positions