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What are USP <797> requirements for hot labs that use Mo-99/Tc-99m generators? Is a negative pressure room a clean environment? Once opened, is a generator considered sterile?
USP <797> requires that generators be stored and eluted in an ISO Class 8 or cleaner air environment (i.e., a clean room). Requirements for environmental quality and control and for personnel practices also apply. A negative pressure room is not necessarily a clean environment. Rather, the ISO Class 8 environment is created by facilities, which typically includes HEPA-filtered air supply, cleaning, and personnel practices.
In an ISO Class 8 environment, with aseptic handling practices and following manufacturer instructions for elution needle protection using the supplied preservative vial (which contains alcohol or parabens as antimicrobial agents), the generator is considered to remain sterile.
Assuming Tc-99m generator eluate is subsequently used to prepare Tc-99m labeled radiopharmaceuticals, such activities must be performed in an ISO Class 5 compounding environment (e.g., laminar flow hood) located in an ISO Class 7 clean room or in a segregated compounding environment.