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Conttrolli Quality of dose calibrator


Accuracy:

evaluate how "precise" measurement dose based on measurement of two "strandard" long half-life, usually, as in our case cesium (137Cs with a half-life of 30 years) and cobalt (57Co with a half-life of 270 days). The average reading of a series of measurements is compared with the values \u200b\u200bof the National Institute of Standards and Technology, if the amount differs by more than 10% you should not use the dose calibrator.

controls are both standards at the time of installation, annually and after any repair technician.

We do on a monthly basis.



Constance

is to ensure that the dose calibrator readings do not vary over time. is obtained by measuring repeatedly a long half-life radionuclide (137Cs). The measure should not vary by more than 10% compared with baseline measurements made at the date of installation of the equipment.
The reading of each energy window or channel is carried out daily and compared with previous readings.


Linearity:

Evaluate the accuracy of the measure on the range of doses used in nuclear medicine. For example, you can measure the highest dose used and repeat the measurement at 6, 24, 30, 48 and 96 hours (or schermarela dose with calibrated screens gradually thicker in order to simulate the decay.
The check should be performed at instalalzione, monthly, and technical operations after repair.



Geometry:

Currency variations in the count due to the geometry of the vessel containing the dose to assess using a standard dose vials with a progressively and then eluted as the difference in readings should not vary however, most from 10% (it is good test for this purpose containers that are used daily such as syringes mainly)
the frequency of monthly and technical operations after repair

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Artifacts

Artifacts

presence of free pertechnetate :
appear salivary glands, stomach, intestinal tract and thyroid

colloidal impurities:
liver and spleen appear

Grosse impurity
appear lungs

Note that hydrophilic impurities are not related protein and weight lipophilic < style="color: rgb(204, 0, 0);"> between 300-1000 daltons can be excreted from the hepatobiliary system.


as Artifacts:

1. Factors related to radionuclide
2. Factors related to the components
3. Factors related to the preparation procedure

The presence in amounts of 99Tc and 99Mo at the expense of 99mTc determine as mentioned, a decrease of technetium 99m tied for free. It follows a change in the biodistribution;

the normal distributions of 99mTc-MIBI (for the study of the myocardium), where these changes are present, will follow a different biodistribution for thyroid and liver.


Factors related to the components

• tin ions, if the reaction would simply be too few, if there are too many forms colloids
• concentrations of reagents: the volume should not be too large. For example DMSA prepared with 2 ml 90% ends up in the kidneys in 15 minutes, while only 10 ml of 70%
  
• number and size of particles : If you inject too little degradation of MAA I ' image and I think wrongly uan hypoperfusion. If they inject too much I will have hot spots in immegini and a "risk" species in a patient already compromise
• Provider Columns and Kits : several columns can contain varying amounts of aluminum or mercaptobenzothiazole neutralized with chlorobutyl stoppers. Behave differently in front of a different column. The same applies to the kit cold.

Factors related to the preparation process

• Mixing: species with protein denaturation can shake gently otherwise
  
• Mixing order: the steps are done in a certain order, such as the first pond and then the chelating radionuclide
• Heating : in some tests to see how those the spleen with red cells is necessary to damage the red blood cells with heat (so that the spleen will Captiva). If you heat them too much they do not break and spleen uptake. If you heat them too little does not damage the spleen and picks them little. In both cases I get a useful diagnostic result.
  
• Incubation : Products "fridge" have to reach room temperature before incubation otherwise is like having an incubation time and reaction time, reduced.
• Coligandi : Depending on coligando that can be used with different chemical species and therefore different biodistribution.
  
• Competing components: attention to substances (such such as plasma) that can act as competitors of the reaction
  
• Solubility: some lipophilic drugs need a certain volume to dissolve
• Anticoagulants: may act as competitors
• oxidation and radiolysis : Some fear the drugs 'air (such as DTPA, HMPAO, HDP), others require a bit' so that air does not form impurities
• Storage : some "drugs" as the labeled leukocytes are required nelal plastic as they tend to stick to the glass
  

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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.

particle size

• 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)

Chemical purity

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:

• 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

• 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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Tests on Radiopharmaceutical Quality Control (2)

Quality control of radiopharmaceuticals:
introduction and Concepts Statement

As the radiopharmaceutical is injected in humans must be checked carefully aclune features:

• Identity
• Quantity
• Quality

Proper quality control of radiopharmaceutical significantly reduces the possibility of errors diagnosis.


dibasic standards for good preparation

The Legislative Decree 178 of 29/5/1991 supplemented by Legislative Decree 44 of 18/02/1997 issued to "Implementation of EU Directives relating to proprietary medicinal products "play, art. 1, paragraph 1:

"It 's intended as a medicine or combination of any substance presented as having properties for treating or preventing disease in human beings or animals and any substance or combination of human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions "So

the radiopharmaceutical is a drug and as such should be subject to the regulations governing drugs.


The radiopharmaceutical is really a drug?

"The term has now Widespread acceptance radiopharmaceutical in nuclear medicine altough These Preparations are better Perhaps Described as "radiodiagnostic agent"
(BJ Baker Treaty of Murray and Eli - 1960)

• pharmacological activity delal molecule bound isotope, if present, is undesired (eg MIBG, Octreoscan etc.).
• The molecule is alal biodistribution but the "active ingredient is the isotope bound to it."
• Adverse reactions described for radiopharmaceuticals are rare and often modest.
• The radiopharmaceutical as well as the Pharmacopoeia is generally controlled by the legislation on radiation protection
  

Neconsegue that the radiopharmaceutical is a drug but a wild neconseguono whole series of regulations 89/343/EEC 187/00, below. What

provide

1. Overall responsibility : nuclear medicine
2. Place of the prepara : nuclear medicine facilities in addition to the
3. quality assurance, taking into account the radioactivity " protect the health risks of ionizing radiation is currently governed by specific national laws. All operations that require the manipulation of radionuclides in order to prepare a radiopharmaceutical should therefore be conducted in compliance with such laws. "
4. They take into account specific aspects of nuclear medicine ignored by the standards of Good Preparation: calculus delal activities specific coltrollo radionuclide impurities, decontamination, disposal of radioactive waste, etc..

NBP: "The preparation and quality control of radiopharmaceuticals must essereeffettuati by skilled and have all the knowledge needed to operate in controlled conditions with unsealed radioactive sources." The practical aspects

can be delegatidallo Technical specialist at Medical Radiology Healthcare (radiographer) or nurse or pediatric nurse, each within their respective professional competences art. 5, paragraph 3 of Decree 187

may be useful to a radiographer download and read the following material:

1. The rules of good preparation of radiopharmaceuticals in nuclear medicine
2. Guidelines for Improving Quality in Nuclear Medicine
3. AIMN-Bed Authority Guidelines for Quality Assurance in PET / CT

• 
  

Path Quality radiopharmaceutical

Preliminary Phase

1. Inspection of Bottle
2. Identification Solution of the radiopharmaceutical
3. recovery
4. stored as recommended
   

Marking

1. running second POS
   
2. labeling of the bottle
3. signature operator

Dispensation

1. preservation of sterility
2. avoid introduction of O2 in the container
3. calida with biological controls
4. quality control of the finished product

Checking the quality of the finished product

1. Purity Purity Chemical
2. radionuclidic
3. radiochemical purity pyrogen
5. pH
6. sterility

The methods for quality control

QC Radionuclides

• multichannel analyzer
• Range Room

QC Chemists Radiochemistry

• high-pressure liquid chromatography (HPLC)
• 
  
• Paper Chromatography Thin Layer Chromatography (TLC)
• Gas chromatography-colorimetric assays
• Spectrometry mass

QC Biological

• LAL test (pyrogenicity)
  
• Infertility
  

instrumentation quality control

1. HPLC

• radiochemical detector ultraviolet detector dirifrazione index, amperometric
• analysis software and data

2. TLC

• Basin for development of TLC plates
• Cromatoscanner; Gamma Camera

3. Multichannel Analizzatire
4. Gamma Camera
5. dose calibrator (Capintec)
6. Gas chromatography

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Quality Control (1)

Purity radionuclidic
(D. Cecchin, F. Bui, University of Padova)

It 's the fraction of the total radioactivity in a source that is present in the form of the radionuclide chosen expressed as a percentage.

When the question arises:

• In the production method of the radionuclide (125I, 123I, present as scrap etc ...)

• the incomplete separation during procedures

• Presence of parents / children (eg: 99Mo with a T1 / 2 of 60 h along with 99mTc with T1 / 2 of 6 h)

Since the 'half-life of radionuclide contaminants can be longer than that of the radionuclide of interest, as in the case of technetium, the proportion of impurities increases over time. This consideration shows that the quality control of radiopharmaceutical to be done immediately before use of the same and not many hours before. As a striking example remember the 201Tl (half-life 73h) that may be contaminated with 202Tl (half-life of 12.2 days).

There are limits tolerated: For example for the product 99mTc generator  99Mo 99mTc where molybdenum is produced by fission are the accepted limits of " 99Mo breakthrough" or the presence of molybdenum eluate should be minimal. To check you can make measurements without and shielding, the vial containing an aliquot of eluate. The shield should be used to mitigate almost all the photons of 140 keV of technetium, but will allow the passage of the photon energy of molybdenum (740 -780 keV).
Correcting the obtained from the radiation shield to measure the attenuation coefficient of the material used for shielding and for the thickness used gives an estimation of molybdenum present in the eluate.


radiochemical purity

It 's the percentage of radioactivity that is present in the form designated

When the question arises:

• Chemical reactions of competition during the marking process

• decomposition by radiolysis of final product

• oxidizing agents and reducing

• Variations in pH and temperature

• Solvents

• Light

be noted that the compounds behave as impure radiochemical different drugs and can have different biodistribution . Often complains about an increase in the background of the image. It follows that in the case of impurities is not useful to inject a dose of radiation. The three species


radionuclides for a drug-related (using tin as a reducing agent) in technetium are

• radiopharmaceutical 99mTc-related (which is the form that I want to get)

• under 99m free form of pertechnetate that has not been reduced by the pool or divalent Sn2 + which was reduced and then oxidized. The consequence is that you can see the bottom of the stomach, thyroid and salivary glands.

• 99mTc IDROSIL or reduced (HR 99mTc), which includes 99mTcO2 (which did not react with the chelating agent) and 99mTc colloid (99mTc-shrunk and consists of Sn2 +-IDROSIL). The consequence of these impurities is that you can see the reticuloendothelial system (liver, spleen, etc ...).

Technetium is in oxidation state 7 + and is not responsive.
Tin technetium than reduces it to +1, +3, +5.



Assessment of radiochemical purity: how?

Analytical methods:

• Thin layer that is the gold standard among the three

• Instant Thin Layer that provides a resolution about how the paper

• Paper cromatography which has the disadvantage of exercise fragile and have a "sensitive child"

Liquid Chromatography (HPLC)

is a method which allows , better than the last, to "quantify". You use a column with a wild series of increasing polarity of solvents used to separate the different radiochemical species.

Advantages:

• is much more precise

Disadvantages:

• is much slower

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• We need much larger doses (volumes of solution) and thus more waste of radiopharmaceutical and irradiazionedel staff.

Analytical methods

1. deposit a drop of test solution on a substrate (usually paper chromatography, which is a film made of fiberglass impregnated with silicone gel)  solid phase
2. It plunges this map in a solvent (liquid phase  or mobile) without wetting the source where it was deposited drop
3. The mobile phase brings with it the various species radionuclidichein relationship to the solubility of species in the solvent used and the link between species and solid phase radiochemical

The solvent front: the band is identifiable on the solid phase where I got ls

The Radiochemical solvent front: is a band where the species comes radiochemistry. The Radiochemical front is known and measured for different species and is used to identify them. Typically

:

• The HR-99m remains the origin

• Il99mTc origin remains free

• The migration linked to the solvent front fiinio

At this point divides the map, the is counted (before then the whole piece) and understand that the percentages of steel. In some cases, the related "travels" with the one or the other impurity, and not alone. In these cases, no use of additional strategies (serial counts and equations for Espar).


Common mistakes

• The spot ends in the solvent or solvents

• old maps or exposed to light
• Map not suitable for the species you want to view
• The solvent is made to continue after the solvent front
• grease from fingerprints
• strip
• Solvent Contamination wrong
• contaminated scissors (used a previous strip)

Estimation of activity of the eluate

It is usually measured in terms of activity / weight (Bq/Kg-1) or as " specific activity".

may be used:

the entire container method:

• is estimated that the container with all the eluate (which I know the volume and weight) in the dose calibrator.

method to rate:

• entire container is taken from a syringe with 1 ml and it counts. (Obviously you should then empty the syringe carlcolare and the residual amount in the needle ...)
  

In other words, the eluate to pass the test must have some activity (as declared by tables issued by the manufacturer of the column).



Yield Generator

E 'necessary, in other words, calculate the theoretical yield is expected to have a generator at a certain time and make sure it matches (within a certain range set) to the actual output of the generator.
typically yields vary between 85% and 95% of the theoretical value.
If the production yield falls below the value specified by the manufacturer, the column must be replaced immediately because complications have arisen irreparable affecting the quality of radiopharmaceutical products.
The consequence is a poor quality of marking which results ultimately in a poor investigation.

factors that decrease the yield are:

• Fluctuations "physiological" in the production of the column. (Just repeat the analysis over time)
• "Channels" in the alumina (in this case with due caution we can "shake" a little 'column in an attempt to close
• Auto-radiolysis: the ionization of water produces radicaliperossidi H2O2 and that being strong oxidants attack the pertechnetate and make unmoveable alumina

factors in place that give a low volume are: Air bubbles

• Pipes blocked
• mechanical problems in the alumina