radiochemistry solutions

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



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



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)



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



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



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



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



Explora summary

Reliable

Powerful

Convenient

Smart

Inexpensive

Flexible

Safe

The superior choice



Explora AC – 11C Acetate module

Produces 11C acetate and other Grignard tracers.

Fully automated with high yields

Decay corrected yields >70%



Explora CN – 11C Cyanide module

For producing 11C amino acid precursors

Produces high yields of 11C HCN or 11C CH4

Decay corrected yields >55%



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



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



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



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)



Explora GN application flexibility

FDG

F-MISO

NaF

FLT

Synthesis and purification options

Seamless integration to purification modules



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



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!



“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



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



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



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

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