X1 Synthesizer
The PET-IFB-X1 synthesizer is the latest generation radiopharmaceutical
Category：
Radiopharmaceutical synthesizer
Key words：
temperature
radioactive
synthesis
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Product description
PET-IFB-X1 synthesizer
The PET-IFB-X1 synthesizer is the latest generation radiopharmaceutical synthesizer from Shaanxi Zhengze Biotechnology Co., Ltd. It has been streamlined and upgraded based on previous generations, integrating all liquid flow paths to fully comply with GMP standards; 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; Adopting high reliability solenoid valves to enhance the overall stability of the system; The synthesis process is carried out in a fully enclosed environment, avoiding interference from external temperature and pressure, and also facilitating the collection of radioactive waste gas; The use of radioactive active substance separation technology can quickly remove contaminated radioactive waste after a single synthesis, and prepare for a second drug synthesis in a very short period of time; PET-IFB-X1 was synthesized by column hydrolysis method, and K222 and residual acetonitrile were almost undetectable in the product using conventional methods. The product meets the technical specifications of the 2020 edition of the Chinese Pharmacopoeia. For users using this synthesizer, the company assists in completing drug registration.
TECHNICAL INDEX
The complete set of equipment includes:
1 synthesizer
1 controller
1 control computer and 1 set of control software
Appearance size
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%
FDG synthesis time: ≤ 25min
FDG radiochemical purity: 99.9% (pharmacopoeia requires greater than 90%)
FDG drug quality indicators: meet or exceed the 2020 edition of the Chinese Pharmacopoeia
(2) 18F-PSMA uncorrected synthesis efficiency: 50 ± 5%
(3) Non calibrated synthesis efficiency of 18F-NaF: ⩾ 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 ranging from 0.6 to 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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World-class performance, attention to detail for high quality
Address:
Xi 'an Economic and technological Development Zone Jingwei New Town Jingwei small and medium-sized Industrial Park No. 2 Workshop 101, 103
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