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Production

Producing a Radiopharmaceutical

Radiopharmaceutical production involves combining chemicals and compounds with radioactive material to create a product. Because an array of radiopharmaceutical variations exist with different traits, the production steps change with each type. However, every radiopharmaceutical produced must undergo a few basic steps that remain similar.

Developers first create a radioactive isotope using a cyclotron, a machine that accelerates protons and transforms them into radioactive isotopes. CMIT usually operates the cyclotron one to two hours a day depending on the amount of radioactive isotopes they need. Once the isotope becomes ready, developers use automated devices called synthesizers to produce the radiopharmaceutical safely and efficiently. While the synthesizer can take up to several hours to finish production, some radiopharmaceuticals like FDG only take 30 minutes to create.

Ensuring the Highest Quality

After developers finish producing the radiopharmaceutical, it must undergo quality control testing, which typically takes 30 to 60 minutes. Unique quality control criteria exist for each type of radiopharmaceutical. Usual tests involved in quality control include specific activity, radiochemical purity, chemical purity, toxicity, sterility and pH. Ph.D. radiochemists and chemistry technologists perform the majority of the work related to radiopharmaceutical production. Ancillary support staff members, such as cyclotron engineers, assist with production as well.