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.

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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.

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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).

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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.

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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

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Qualification and validation activities

Our activities are carried out by a specialized department, with classified operators from the point of view of radiation protection.

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