ABSTRACT
Radiopharmaceuticals fall into two categories, firstly those produced with a half-life of sufficient length to allow normal sterility testing. The biggest difference between sterility testing of normal pharmaceuticals and of radiopharmaceuticals is that the testing of the latter has to be done retrospectively. However, most radiopharmaceuticals are formulated and used within a week and there is thus not enough time to carry out the standard sterility testing procedures. Pharmaceuticals, which because of the nature of their use are required to be sterile, are routinely required to pass a sterility terst. The biggest difference between sterility testing of normal pharmaceuticals and of radiopharmaceuticals is that the testing of the latter has to be done retrospectively. In theory then, it is perfectly possible for bacteria to be introduced into a radiopharmaceutical, survive the storage period and be injected in a viable state into the patient. Moreover, many patients receiving radiopharmaceuticals may be receiving cancer chemotherapy which can compromise the immune system.
