In This Section
Can the preparation of radiopharmaceuticals be considered under the
The majority of radiopharmaceuticals can be prepared as Low-Risk Level CSPs with 12-Hour or Less BUD.
USP <797> states "radiopharmaceuticals compounded from sterile components in closed sterile containers and with a volume of 100 mL or less for a single-dose injection or not more than 30 mL taken from a multiple-dose container shall be designated as, and conform to, the standards for Low-Risk Level CSPs." These standards include the placement of a certified ISO Class 5 laminar airflow hood in an ISO Class 8 or cleaner air environment. However, USP <797> allows low-risk level radiopharmaceuticals with 12-hour or less BUD to be prepared in a segregated compounding area (with air quality that is worse than ISO Class 8). A line of demarcation defining the segregated compounding area shall be established. Materials and garb exposed in a patient care and treatment area shall not cross a line of demarcation into the segregated compounding area." Of course, other requirements also apply, including preparation of the CSPs in an ISO Class 5 environment (e.g., laminar airflow hood), procedures for personnel training and competency evaluation, cleansing and garbing, cleaning and disinfecting the area, and environmental sampling.
Some radiopharmaceuticals, however, require preparation in better air quality environments than that afforded in segregated compounding areas. Elution of Tc-99m generators must be performed in ISO Class 8 or cleaner environments, and medium-risk level CSPs (e.g., radiolabeled leukocytes) must be performed in an ISO Class 5 hood inside an ISO Class 7 clean room.