TABLE 3

Radiopharmaceutical Preparation Requirements

FunctionImmediate useBeyond immediate use
Preparation areaHot lab with ambient room airSegregated radiopharmaceutical processing area or clean room
Cleaning or disinfection of preparation areaRequiredRequired
Quality control testing of final productRequiredRequired
Garbing and hand hygieneRequired (clean lab coat)Required (full garbing)
Aseptic technique trainingRequiredRequired
PEC (hood) useNot requiredRequired
Gloved fingertip or thumb sampling testNot requiredRequired
Media-fill testNot requiredRequired
Aseptic manipulation competency testNot requiredRequired