Mayo Clinic approaches to meet United States Pharmacopeia <797> requirements for facility design and environmental controls of nuclear pharmacy.

UNLABELLED

According to the United States Pharmacopeia (USP) General Chapter <797> (USP <797>), "Pharmaceutical Compounding-Sterile Preparations," the compounding facility must be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. The goal of the project was to evaluate the appropriateness and effectiveness of our approaches in meeting <797> requirements.

METHODS

USP <797> standards, radiation safety concerns, and work-flow patterns were the focal points in our assessment of 4 laboratories: 2 nuclear pharmacy laboratories that engage in preparing sterile (low-, medium-, and high-risk levels), nonsterile, or possible hazardous radioactive drugs and 2 other laboratories in which only low-risk-level preparations are involved.

RESULTS

Each laboratory was constructed with a physically separated International Organization for Standardization Class 7 anteroom and clean room to allow us to maintain an appropriate air quality, a consistent operation, and a desirable flexibility. An isolated area within the laboratory was designated for preparing nonsterile products. Higher air change per hour was used in the areas with higher traffic or smaller space. Lead-lined biological safety cabinets (BSCs) were segregated and used depending on the risk category of the preparations. In 1 laboratory, the exhaust flow for the BSC was too great, and a lead-lined compounding aseptic containment isolator (CACI) was installed. Air in the BSC and CACI was 100% exhausted to the atmosphere. 99Mo/99mTc generators were placed in the negative-pressure clean room to ensure a more efficient operation and cleaner air environment. Clean-room equipment (i.e., keyboards, printers, and telephones) was installed, and refrigerators or freezers and the central-processing unit of each computer were placed outside clean room.

CONCLUSION

Our wide-range preparations of sterile, nonsterile, or potential hazardous radiopharmaceuticals, coupled with the limited space of each laboratory and existing antiquated mechanical systems, presented a challenge. Nevertheless, we successfully remodeled each nuclear pharmacy laboratory to meet USP <797> requirements for facility design and environmental controls.