Services for Radiopharmacies and Nuclear Medicine
There is a wide range of consulting services offered by ItelPharma for radiopharmacies
Sterility Test
Sterility tests verify the absence of microbial contamination potentially harmful for humans in raw materials and finished products.
Radionuclide purity test
The test of radionuclide purity of radiopharmaceuticals is performed to verify that the content of long half-life impurities present in the sample meets the acceptance criteria defined by the European Pharmacopoeia.
Bioburden test
Bioburden test is used to determine the quantity of viable microorganisms present in the bulk solution of an injectable radiopharmaceutical product before sterilization (for terminally sterilized radiopharmaceuticals) or filtration (for radiopharmaceuticals products aseptically).
Environmental Monitoring
The microbiological monitoring of classified environments allows to assess the microbial concentration present in the air and on the surfaces of the environments according to GMP guidelines.
Training on GMP
ITEL is organizing at its Radiopharmacy (ITELPHARMA®) theoretical and practical training courses in order to train professionals in the field of radiopharmaceuticals
Qualification and validation activities
Our activities are carried out by a specialized department, with classified operators from the point of view of radiation protection.