Tests on Radiopharmaceutical
visual inspection
- It 's a rough thing to do quickly and is very important percgè need to grasp "in flight" as gross errors (exchange vials etc. ..) remember for example that the pertechnetate is transparent while the MAA are a bit 'cloudy, whitish during preparation. E 'murky Nanocoll also for the study of sentinel lymph nodes.
- for radiopharmaceuticals containing particles may be useful to use a microscope with a grid cell count to estimate the number and size of the particles. (MAA 10000-90000 nm, 100-1000 nm colloidal sulfur)
Examples of chemical impurities are aluminum ion Al3 + in the eluate of the generator, the traces of iron in India hydrochloride (OctreoScan, oncoscint or marking of platelets) or small amounts of iodine in the free radioiodine. Aluminum is one of the most common contaminants and more "dangerous" for labeling because it can combine with colloids flocculate and become insoluble (as it is picked up by the reticuloendothelial is concentrated in the liver).
There are limits
must be careful that there are> 10 micrograms of aluminum per ml of eluate (technetium).
Aluminium as to determine the concentration
Use a colorimetric method: on a special map and deposit a drop of eluate at the other end of the map a drop of known concentration of aluminum. The color intensity map taken at Dalal delal goccaidi eluatode there be less than that of n gocciai known concentration. Otherwise, the test failed and the column should be sent back to the sender.
Common causes of loss of aluminum from the column are:
acidity
Common causes of loss of aluminum from the column are:
- heating column
- acid treatment of the albumin (now quite rare with modern columns)
acidity
Almost all radiopharmaceuticals are between pH 4 and pH 8 with a few exceptions:
- Iodine is maintained in an alkaline solution because otherwise tend to become volatile
- India is kept in acid solution because in this way has less tendency to form insoluble products.
- The 99mTc-HMPAO generally has a pH between 9-9.8
The purpose of controlling acidity, enforceable by a technique similar to that for the monitoring of aluminum, or with a colorimetric method, is to check Chei compounds maintain the pH stability, and thus their biodistribution properties, marking etc ...
Infertility
The International Pharmacopoeia has recognized that it is difficult to assess the sterility of a radiopharmaceutical because of the short half-life of the same. As a result, in general, you are authorized to use the preparations before the results of sterility. This does not allow, of course, never do the checks. Unfortunately
bacteria, although rarely, can grow in preparations but their growth is not sustained over time. How then to find out if the product was sterile the injection? It is generally considered sufficient to remedy the problem take samples of the second and final elution, filter through a Millipore and transfer them to culture medium.
pyrogenicity
The pyrogen is a substance that, when injected, it increases the temperature (especially the pyrogens are lipopolysaccharides delal bacterial cell wall). If the volume of the preparation is low (< style="font-weight: bold;"> Contamination corpuscular
should also avoid contamination of any kind corpuscular (powder, silk fiber, talc etc.).. Popssono rilavate be using a polarized lens, in the case of large particles.
Other important recommendations
Infertility
The International Pharmacopoeia has recognized that it is difficult to assess the sterility of a radiopharmaceutical because of the short half-life of the same. As a result, in general, you are authorized to use the preparations before the results of sterility. This does not allow, of course, never do the checks. Unfortunately
bacteria, although rarely, can grow in preparations but their growth is not sustained over time. How then to find out if the product was sterile the injection? It is generally considered sufficient to remedy the problem take samples of the second and final elution, filter through a Millipore and transfer them to culture medium.
pyrogenicity
The pyrogen is a substance that, when injected, it increases the temperature (especially the pyrogens are lipopolysaccharides delal bacterial cell wall). If the volume of the preparation is low (< style="font-weight: bold;"> Contamination corpuscular
should also avoid contamination of any kind corpuscular (powder, silk fiber, talc etc.).. Popssono rilavate be using a polarized lens, in the case of large particles.
Other important recommendations
- gloves, if possible without talc
- Use tissue paper or paper towels in the absence type
- Change needles and syringes (if required) nellefasi intermediate preparation
- Label
- CLEANING ( hoods, filters, pipettes, test tubes, centrifuges, screens, etc.).
- ORDER ACCURACY
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