In This Section
Specific Questions about USP <797> – Generators and Other Devices
Where should a Moly generator be stored and eluted?
A Moly generator should be stored and eluted in an ISO Class 8 or cleaner air environment.
How does USP affect the use of 82Rb generator(s) in the imaging room?
Because the eluate is directly administered to the patient, USP does not apply.
The Intego™ PET Infusion System (Medrad, Inc., Indianola, PA) is an automatic injector for 18F-FDG (see more detailed description of this device under the "More Information" link below) and has been recently approved by the FDA. Does use of the Intego™ PET Infusion System meet the requirements as stipulated in the USP ?
USP is not applicable to the administration aspect of the Intego™ PET Infusion System; however, the insertion of two needles (one for venting purpose and the other for drawing dose) into the multidose 18F-FDG vial should be carried out in an ISO Class 8 or cleaner air environment if administrations take place beyond 1 hour. If all administrations are completed within 1 hour of puncture of the 18F-FDG vial, the immediate-use exemption may apply.
Does USP apply to use of the BVA-100 Blood Volume Analyzer (Daxor Corporation, New York, NY)?
Since the BVA-100 Blood Volume Analyzer is not designed to compound, handle, manipulate, or use sterile product to be administered to human subjects, USP is not applicable to its use.
Is the preparation process of SIR-Spheres® (Sirtex Medical Limited, Lane Cove, Australia) or TheraSphere® (MDS Nordion, Ottawa, Canada) 90Y microspheres subject to USP requirements?
Strictly no, but ethically yes.
What are USP 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 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.