EQUIPMENT FOR PRODUCTION OF PHARMACEUTICALS
SOLUTIONS FOR INDUSTRIAL RADIOPHARMACIES
Radionuclide extraction technologies and new models of Tc-99m, Y-90, Re-188 [and other radionuclides] semi-automatic generator systems (centrifugal semi-countercurrent extraction generator modules).
Possible targets:
- Natural Mo trioxide target irradiated in a nuclear reactor
- Mo-98 trioxide target irradiated in a nuclear reactor
- Mo-100 target irradiated by a cyclotron beam
- other possibilities
Successfully used in:
- Russian research centers and laboratories
- Private and public medical clinics and centers
- Medical centers and laboratories in Germany and Switzerland, the USA and South Korea.
Tc-99m SYSTEM PARAMETERS
The basic parameters of the Tc-99m generator system:
• the total activity of the Mo-99 & Tc-99m mixture – up to 30 Ci;
• the Tc-99m extract separation takes about 6-8 min;
• the final product yield is more than 90%;
• the radiochemical purity is higher than 98%;
• the extract volume is not more than 50 cm(3);
• the Mo-99 content in the final product does not exceed 2·10-3 %.
• the concentration of MEK (methylethylketone) in the solution of Tc-99m is not more than 0,5 [mg]/[ml].
• pH of the Tc-99m aqueous solution is within the range of 5.0-7.0
• total time of the final product preparation is less than 1,5 hours.
• no radioactive waste problems!
Can be supplied with target reprocessing unit and started material (Mo(nat) or Mo-98)
Tens of hospitals annually provided with thousands of Tc-99m doses eluted from these industrial generator systems. The quality of Tc-99m is in full compliance with the highest pharma standards; in the meantime the cost of the product is lower compare to solutions obtained within the usual technology.
The basic parameters of the Tc-99m generator system:
• the total activity of the Mo-99 & Tc-99m mixture – up to 30 Ci;
• the Tc-99m extract separation takes about 6-8 min;
• the final product yield is more than 90%;
• the radiochemical purity is higher than 98%;
• the extract volume is not more than 50 cm(3);
• the Mo-99 content in the final product does not exceed 2·10-3 %.
• the concentration of MEK (methylethylketone) in the solution of Tc-99m is not more than 0,5 [mg]/[ml].
• pH of the Tc-99m aqueous solution is within the range of 5.0-7.0
• total time of the final product preparation is less than 1,5 hours.
• no radioactive waste problems!
Can be supplied with target reprocessing unit and started material (Mo(nat) or Mo-98)
Tens of hospitals annually provided with thousands of Tc-99m doses eluted from these industrial generator systems. The quality of Tc-99m is in full compliance with the highest pharma standards; in the meantime the cost of the product is lower compare to solutions obtained within the usual technology.
Y-90 SYSTEM PARAMETERS
The basic parameters of the Y-90 generator system:
• the first unit is used for the separation of Y-90 from Sr-90 at the first stage and for washing the Y-90 extract at the second stage;
• the second unit is used for the deep purification of Y-90 from Sr-90 and Y-90 stripping.
• then re-extract of Yttrium-90 is passed to the third extractor to remove trace quantities of extragent. The re-extract is then treated for purification from inactive impurities (Fe, Al, Ni) by the sorption method. After purification Y-90 solution, it enters the evaporation and the final product is obtain in the chloride form (0.1M HCL) in any volume.
• total activity of the initial radionuclide mixture is in a wide range from trace amounts to 10 – 15 Ci per 1 cycle;
• the final product yield is up to 90%;
• the Sr-90 impurity does not exceed 10-5 % - 10-6 % at the date of calibration;
• the total time for the final product (YCl3) preparation is about 8 hours, of which 1.5 hours are applied to the extraction part, while the other methods used to obtain Y-90 take 20 ÷ 24 hours;
• the extract volume is within 40-50 ml.
• The generators are made of metallic niobium (for HCl) or stainless still (for HNO3).
The basic parameters of the Y-90 generator system:
• the first unit is used for the separation of Y-90 from Sr-90 at the first stage and for washing the Y-90 extract at the second stage;
• the second unit is used for the deep purification of Y-90 from Sr-90 and Y-90 stripping.
• then re-extract of Yttrium-90 is passed to the third extractor to remove trace quantities of extragent. The re-extract is then treated for purification from inactive impurities (Fe, Al, Ni) by the sorption method. After purification Y-90 solution, it enters the evaporation and the final product is obtain in the chloride form (0.1M HCL) in any volume.
• total activity of the initial radionuclide mixture is in a wide range from trace amounts to 10 – 15 Ci per 1 cycle;
• the final product yield is up to 90%;
• the Sr-90 impurity does not exceed 10-5 % - 10-6 % at the date of calibration;
• the total time for the final product (YCl3) preparation is about 8 hours, of which 1.5 hours are applied to the extraction part, while the other methods used to obtain Y-90 take 20 ÷ 24 hours;
• the extract volume is within 40-50 ml.
• The generators are made of metallic niobium (for HCl) or stainless still (for HNO3).
Re-188 SYSTEM PARAMETERS
The basic parameters of the Re-188 generator system:
• Re-188 yield exceeds 90%;
• radiochemical purity exceeds 96%;
• pH of the Re-188 aqueous solution is within the range of 6.5-7.0;
• the extract volume is not more than 50 cm(3);
• the Re-188 extraction separation takes about 6-8 min;
• the admixture of W-188 does not exceed 1*10(-5) of Re-188;
• total time to get the final product is not more than 90 minutes
The developed technology and equipment allow obtaining of W-188 solution up to 5 Ci and Re-188 solutions with high specific activity and very low content of inorganic contaminants. The latter is very important when introducing Re-188 into antibodies and peptides.
The half-life of the parent radionuclide W-188 is 69 days, which makes it possible to use one Re-188 generator for 4-6 months, depending on the activity of W-188 loaded into the generator.
A facility for producing Re-188 commenced its operation in RUSATOM Institutes, St. Petersburg. The same technology is now producing Re-188 medical supplies at radiopharma plant "Medradiopreparat" in Moscow.
The basic parameters of the Re-188 generator system:
• Re-188 yield exceeds 90%;
• radiochemical purity exceeds 96%;
• pH of the Re-188 aqueous solution is within the range of 6.5-7.0;
• the extract volume is not more than 50 cm(3);
• the Re-188 extraction separation takes about 6-8 min;
• the admixture of W-188 does not exceed 1*10(-5) of Re-188;
• total time to get the final product is not more than 90 minutes
The developed technology and equipment allow obtaining of W-188 solution up to 5 Ci and Re-188 solutions with high specific activity and very low content of inorganic contaminants. The latter is very important when introducing Re-188 into antibodies and peptides.
The half-life of the parent radionuclide W-188 is 69 days, which makes it possible to use one Re-188 generator for 4-6 months, depending on the activity of W-188 loaded into the generator.
A facility for producing Re-188 commenced its operation in RUSATOM Institutes, St. Petersburg. The same technology is now producing Re-188 medical supplies at radiopharma plant "Medradiopreparat" in Moscow.