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C5 Synthesizer

The PET-IFB-C5 synthesizer is the latest generation radiopharmaceutical synthesizer

Category:

Radiopharmaceutical synthesizer

Key words:

synthesizer

temperature

synthesis


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Product description

PET-IFB-C5 multifunctional synthesizer

The PET-IFB-C5 synthesizer is the latest generation radiopharmaceutical synthesizer from Shaanxi Zhengze Biotechnology Co., Ltd. It has been upgraded based on previous generations, integrating all liquid flow paths and fully complying with GMP standards; One loading can synthesize five batches of 18F-FDG; The synthesis process is carried out in a fully enclosed environment, avoiding interference from external temperature and pressure and facilitating the collection of radioactive waste gas; Different flow path plates can be used to synthesize drugs such as 18F-FDG, 18F-PSMA, 18F-FLT, 18F-NaF, 177Lu, etc. Especially, the uncorrected synthesis efficiency of 18F-PSMA can reach 50%. Using color code recognition to mark pipelines effectively prevents errors; Simple and easy-to-use user interface, drag and drop interface editing, allowing users to freely edit new interfaces according to their needs.

 

TECHNICAL INDEX

The complete set of equipment includes:

1 synthesizer

1 controller

1 control computer and 1 set of control software

Appearance dimensions:

Synthesizer: height x width x depth: 300x300x400mm (placed in a hot room)

Controller: Height x Width x Depth: 220x355x400mm (placed outdoors)

Temperature control system:

Heating rate: 25 ℃ to 120 ℃, time 10s ± 2s

Temperature accuracy: error<3%

Number of thermostats: 1

Cooling rate: 120 ℃ -50 ℃, time 60s ± 2s

Temperature accuracy: error<3%

Interlocking: Hardware and Software

Radioactive detector:

Type of radioactive detector: GM counter tube or semiconductor

Number of radioactive detectors: 3 or more

Detection range: 1mci~3ci

Detection accuracy: error<10%

Technical indicators for drug production:

( 1 ) 18F-FDG

FDG uncorrected synthesis efficiency: 70 ± 5%

Radiochemical purity of FDG: ⩾99.9% (pharmacopoeia requires greater than 90%)

FDG synthesis time: ≤ 25min

FDG drug quality indicators: meet or exceed the 2020 edition of the Chinese Pharmacopoeia

(2) Non calibrated synthesis efficiency of 18F-P SMA: 45 ± 5%

(3) 18F NaF uncorrected synthesis efficiency: ⩾95%

(4) 18F-FLT

(5) 177LU tagged peptide

(6) 68Ga tagged peptide

Control system:

Software interface type: TCP/IP

Communication cable: Ethernet cable Remote control: Yes

Mobile control: Yes

Computer: desktop PC or laptop, Windows operating system.

Power:

Standby mode: 45W

Working status: 350W

Peak state: 1000W (less than 10 seconds)

 

Working conditions

Environmental temperature:

The ambient temperature ranges from 15 ℃ to 35 ℃; Relative humidity ≤ 85%; The air pressure is not limited.

Gas source requirements:

Nitrogen, purity ⩾99.9%;

Compressed air: pressure of ⩾0.6-0.8 MPa, with a ⩾0.6 cubic meter gas storage tank. A 12mm diameter air pipe is required from the gas tank to the equipment, and pure air without oil or water is used.

Hot room requirements:

The internal net size can accommodate the synthesizer, with 300mm left in the front and rear directions, 200mm left in the up and down directions, and 200mm left and right directions for maintenance or expansion space.

Power Supply:

There is a 220V 10A three core power socket within and outside the hot room, with a zero to ground voltage of 1 V, grounded and a resistance of ⩽10Ω.

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