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放射性药物
制药
ATMP 细胞和基因治疗
服务
警告！本页内容仅提供以下语言版本： 英语
Customer
NCBJ POLATOM | Otwock, Poland
Customer Challenge
Build a cGMP Tc-99m Generator Production Line, with terminal sterilization and 100% in-line QC testing (elution constancy, 99Mo breakthrough, calibration).
Performance Requirements – NCBJ Polatom
- Batch size: 250 generators, two batches per week
- Maximum batch activity of Mo-99:1,000 Ci on the date of production
- Batch production time: approx. 10 hours, by 4-5 operators
Solution Highlights
Semi-automatic line for the Tc-99m generator production in GMP. The plant allows the loading from B(U) of the 99Mo bulk, the formulation and adjustment of the chemical parameters of the solution, the loading of the 99Mo in the generator column, the autoclave sterilization of the columns, the semi-automatic assembly and the 100% QC verification of each generator. The line is therefore equipped with a series of progressive-shielding chambers able to keep safe all the plant interlocking operations, from the high-activity bulk loading to the final washing and QC operations. The double pass-through autoclave allows a transfer of the loaded columns with a one-way transfer of the material for an optimal process flow.
Technical Features
Number of working chambers
- 12
Type of process:
- Terminal sterilization
Type of shielding:
- Lead 150mm / Lead 100mm
Automation systems available:
- Automatic 99Mo formulation
- Automatic filling of generator columns
- Automatic washing of generator columns
Particularly interesting features:
- Automatic in-line QC for 99Mo breakthrough during filling
Productivity:
- 250 generators in 12 hours, 3 batches per week
地点: Otwock
类别: Radiopharma
