The challenge and importance of GMP management of positron emission tomography (PET) drug processes is underscored by FDA in a new guidance released in October on PET media fills and exemplified by a recent recall of a prominent PET generator.
In late July, Bracco Diagnostics initiated a recall of it CardioGen-82 after patients who received diagnostic procedures two to four months earlier set off radiation scanners at US airports.
The patients received more radiation than expected apparently due to a hospital user error and/or an equipment malfunction that caused strontium to be inadvertently released into the preparation.
The rubidium (Rb-82) used in the procedure is collected from the generator column by injecting a solution of saline through the column. Under normal conditions, only the Rb-82 is released into the solution, while the strontium remains attached to the column. Strontium has a half-life of 25 days, whereas rubidium-82 has a half-life of 75 seconds.
CardioGen-82 consists of a generator used at clinical sites to produce rubidium-82 chloride injection and is one of a variety of nuclear medicine scans that use radioactive drugs to evaluate the heart. All units have now been recalled, exacerbating a shortage of the imaging drug that began in January.