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Mayo approaches to meet USP <797> requirements for nuclear pharmacy’s facility design and environmental controls

¹ Mayo Clinic, Rochester, Minnesota

1301

Objectives: Per USP <797>, the compounding facility must be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. The project’s goal was to evaluate the appropriateness and effectiveness of our approaches in meeting <797> requirements.

Methods: <797> standards, radiation safety concerns, and work flow patterns were the focal points in our assessment of two nuclear pharmacy labs which engage in preparing sterile (low/medium/high-risk levels), nonsterile or possible hazardous radioactive drugs, and two other labs involve only low-risk level preparations.

Results: Each lab was constructed with physically separated ISO Class 7 ante and buffer areas to allow us in maintaining an appropriate air quality, a consistent operation, and a desirable flexibility. Isolated area within the lab was designated for preparing non-sterile products. Higher air change per hour was employed in the area with higher traffic or smaller space. Lead-lined biological safety cabinets (BSC) were segregated and used per the risk categories of the preparations. As the exhaust flow for BSC was too great for one lab, a lead-lined compounding aseptic containment isolator (CACI) was installed. Air in BSC and CACI was 100% vented to the atmosphere. Tc-99m generator was placed in the buffer area to ensure a more efficient operation and cleaner air environment. Clean room equipment (i.e., keyboards, printers, telephones) was installed whereas refrigerators and CPU’s were placed outside clean room.

Conclusions: Our wide-range compounding of sterile, non-sterile or potential hazardous radiopharmaceuticals coupled with limited space of each lab and existing antiquated mechanical system presented a challenging task to us. Nevertheless, we have successfully established a much safer and efficient working environment in each lab.

This Article Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Google Scholar Articles by Hung, J. Articles by Anderson, M. PubMed Articles by Hung, J. Articles by Anderson, M.