Automated Synthesizers and Dispensers for Good Radiopharmaceutical Production

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GRP™ modules – the technical dimension:

  • Your attractive solution for all your tracer synthesis needs
  • Your reliable basis for GMP conformant routine production
  • Your flexible basis for all your R&D labeling projects
  • Your customizable and expandable base that grows with your demands
  • Your option for reliable dispensing and monitoring
  • Your solution for both imaging and therapeutic agents
  • Your “easy as a smartphone” operable device thanks to intuitive operation via
    GRP™-Interface software read more

 

The components of the GRP™ system are designed to stack directly above one another in order to minimize module footprint and save expensive hot cell space. Alternatively, the stacking may be back set using a special mounting plate to provide further synthesis options and to conform to customers’ hot cells.
Only one single GRP™-unit is necessary to e.g. produce, apart from 18F-FDG and 18F-Fluoride, also other commonly used tracers such as 18F-FET, 18F-FLT, 18F-FMC and 18F-FMISO.
This makes GRP™ the most compact and flexible system on the market.

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GRP™ modules – the pharmaceutical dimension:

GRP™ cassettes are available for almost all currently and commonly used PET tracers and the list of cassettes for GMP production of diagnostic and therapeutic tracers is continuously expanding. For more Information or inquiries regarding cassettes and chemicals please contact info@scintomics or call +49 8171 150 55-0.

 

GRP™-cassette-kits are produced under GMP conformant conditions and are delivered with extensive GMP documentation. In addition to standard tracer kits, SCINTOMICS offers synthesis kits for some of the most innovative and promising recently discovered biomarkers. They include, for example, Pentixafor (CXCR4-ligand), HA-Dotatate (SST-receptor antagonist), Avebetrin (αvβ3-antagonist) or several PSMA agents (PSMA-HBED/PSMA I&T/PSMA-DKFZ-617 (GCP II inhibitor) for imaging and therapy. For these tracers cassette kits are available for GRP™-modules, for Pentixafor excluisvely from Scintomics.
For researchers wishing to develop custom tracers, additional valve manifolds, plastic reactors and further accessories are available from SCINTOMICS.

GRP module 2V:

Fully automated GMP cassette module for the production of 68Ga-fractionated-tracers, 177Lu-compounds and 11C-Choline

GRP module 2V – components:

Reactor unit

Reactor module for heating of sterile plastic vials to up to 140°C; vacuum pump included, stainless steel, stackable, RS 485 Bus connection; 24 V DC.

Master valve unit

The master valve unit is a fivefold motor valve unit for sterile single use valve manifolds, stainless steel, stackable, bus connection, 24V DC. The design protected rapid manifold fastening system ‘soft-lock’ allows the fast and simple changing of cassettes.

Detector unit

Detection unit with two build-in pressure sensors for positive (filter integrity test) and negative pressure, a mass flow controller for inert gases as well as three activity sensors (C1 and C2 type PP+ with capillary fixation and C3 type PP with cartridge holder or capillary fixation) inclusive, stainless steel, stackable, 24V DC.

1 Second valve unit

Same as the master valve unit, but operated as a slave.

Syringe unit

Dispensing and liquid transfer unit for dispensing into sterile syringes and vials, transfer of liquids during GRP module based syntheses.

SCINTOMICS Control Center (SCC™) Software

GMP/FDA 21 CFR part 11-compatible software for controlling GRP™ modules, installed under Windows, with accompanying software manual. read more

SCINTOMICS GRP™ Interface

Unique touch screen operated simplified user interface for routine GMP production on a laptop PC with foldable touch screen under Windows. read more

GRP module 3V:

Fully automated GMP cassette module for the production of all Tracers that can be done with the 2V module plus 68Ga-peptide (cationic) tracers, 18F-FDG, 90Y-therapeutics

GRP module 3V – components:

Reactor unit

Reactor module for heating of sterile plastic vials to up to 140°C; vacuum pump included, stainless steel, stackable, RS 485 Bus connection; 24 V DC.

Master valve unit

The master valve unit is a fivefold motor valve unit for sterile single use valve manifolds, stainless steel, stackable, bus connection, 24V DC. The design protected rapid manifold fastening system ‘soft-lock’ allows the fast and simple changing of cassettes.

Detector unit

Detection unit with two build-in pressure sensors for positive (filter integrity test) and negative pressure, a mass flow controller for inert gases as well as three activity sensors (C1 and C2 type PP+ with capillary fixation and C3 type PP with cartridge holder or capillary fixation) inclusive, stainless steel, stackable, 24V DC.

2 second valve units

Same as the master valve unit, but operated as a slaves.

Syringe unit

Dispensing and liquid transfer unit for dispensing into sterile syringes and vials, transfer of liquids during GRP module based syntheses.

SCINTOMICS Control Center (SCC™) Software

GMP/FDA 21 CFR part 11-compatible software for controlling GRP™ modules, installed under Windows,  with accompanying software manual. read more

SCINTOMICS GRP™ Interface

Unique touch screen operated simplified user interface for routine GMP production on a laptop PC with foldable touch screen under Windows. read more

GRP module 4V:

Fully automated GMP cassette module for the production of all the tracers that can be done with 2V and 3V modules plus most 18F-tracers.

GRP module 4V – components:

Reactor unit

Reactor module for heating of sterile plastic vials to up to 140°C; vacuum pump included, stainless steel, stackable, RS 485 Bus connection; 24 V DC.

Master valve unit

The master valve unit is a fivefold motor valve unit for sterile single use valve manifolds, stainless steel, stackable, bus connection, 24V DC. The design protected rapid manifold fastening system ‘soft-lock’ allows the fast and simple changing of cassettes.

Detector unit

Detection unit with two build-in pressure sensors for positive (filter integrity test) and negative pressure, a mass flow controller for inert gases as well as three activity sensors (C1 and C2 type PP+ with capillary fixation and C3 type PP with cartridge holder or capillary fixation) inclusive, stainless steel, stackable, 24V DC.

3 additional valve units

Same as the master valve unit, but operated as a slaves.

Syringe unit

Dispensing and liquid transfer unit for dispensing into sterile syringes and vials, transfer of liquids during GRP module based syntheses.

SCINTOMICS Control Center (SCC™) Software

GMP/FDA 21 CFR part 11-compatible software for controlling GRP™ modules, installed under Windows, with accompanying software manual. read more

SCINTOMICS GRP™ Interface

Unique touch screen operated simplified user interface for routine GMP production on a laptop PC with foldable touch screen under Windows. read more

GRP customized configurations:

Fully automated GMP cassette modules for multi-purpose research applications

GRP module R&D configuration with compact prep HPLC

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2 GRP module cassette sytems in 1 hot cell

GRP Capillary module:

Freely configurable capillary module system with fixed tubing for e.g. 68Ga-tracer or 177Lu-compound synthesis

GRP capillary module – components:

Reactor unit

Reactor module for heating of sterile plastic vials to up to 140°C; vacuum pump included, stainless steel, stackable, RS 485 Bus connection; 24 V DC.

Master capillary unit

The master capillary solenoid valve unit is a tenfold valve unit for synthesis of radiotracers with a fixed tubing. The housing is made of stainless steel, stackable, bus connection, 24V DC. The most relevant disposables such as storage vials and filled syringes or the reactor vessel are available as ready-to-use consumable package. Thus the system is a combination of a classical module with fixed tubings and a cassette based module, reducing the costs for each synthesis while maintaining in part the comfort of syntheses by manifolds.

Detector unit

Detection unit with two build-in pressure sensors for positive (filter integrity test) and negative pressure, a mass flow controller for inert gases as well as three activity sensors (C1 and C2 type PP+ with capillary fixation and C3 type PP with cartridge holder or capillary fixation) inclusive, stainless steel, stackable, 24V DC.

1 Second capillary unit

Same as the master capillary unit, but operated as a slave.

Syringe unit

Dispensing and liquid transfer unit for dispensing into sterile syringes and vials, transfer of liquids during GRP module based syntheses.

SCINTOMICS Control Center (SCC™) Software

GMP/FDA 21 CFR part 11-compatible software for controlling GRP™ modules, installed under Windows 10, with accompanying software manual. (link to “Products_Software_Scintomics Control Center”)

SCINTOMICS GRP™ Interface

Unique touch screen operated simplified user interface for routine GMP production. (link to “Products_Software_GRP Interface”) on 15” Laptop PC with foldable touch screen and Windows 10.

The GRP™ series of modules is the most compact on the market. It can be installed e.g. in a SCINTOMICS customized hot cell. Very little is necessary in addition:

Space

Please note the dimensions from the drawing on the right. Additional 100 mm of space are required in the back of the modules. Each additional valve module will add 73 mm to the height of the system.

Electrical and electronic connections

Electrical and data transfer cables require a free and accessible port or feed through.

Cables

1 electrical cable for the synthesis module (8 mm Ø – plug: 30 mm Ø)
1 data transfer cable from synthesis module to notebook (cable: 5 mm Ø – plug: 15×15 mm²)

Media requirements

For mass flow controller: Nitrogen (4 ± 0.5 bar), optionally other gases usable (please contact SCINTOMICS before connection).
NOTE: Suitable adapters to connect tubing (O.D. 3.2 mm) to the nitrogen outlet and a gauge need to be provided.
For reactor cooling, if required: Nitrogen or compressed air (4 ± 0.5 bar)
NOTE: Suitable adapters to connect tubing (e.g. polyurethane, O.D. 6mm, ID 4mm) to the gas outlet and a gauge need to be provided.
Suitable tubing, gauges and adapters can be provided on request.

Miscellaneous

Additional space outside the hot cell is needed for a standard 15” Laptop PC and a 24V power supply (90 x 252 x 43.8 mm³ (WxDxH)).
An electrical outlet (100-240 VAC (50/60 Hz), 16A) outside the hot cell is needed to plug in the laptop and the power supply.
Alternatively, if an electrical outlet (100-240 VAC (50/60 Hz), 16A) is available inside the hot cell, the power supply may be placed inside.
Power extension cables can be provided on request.