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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