USP <797> outlines three risk levels for compounding sterile preparations: low, medium, and high. The risk level is determined based on the likelihood of contamination, the number of manipulations involved in compounding, and the environment in which compounding occurs.
For low-risk compounding, which involves aseptic manipulations using only sterile components and equipment, the minimum requirement for environmental monitoring is an annual evaluation of air quality and surface contamination.
For medium-risk compounding, which involves multiple sterile products or manipulations, the minimum requirement is semi-annual environmental monitoring, as well as additional testing of equipment and personnel.
For high-risk compounding, which involves non-sterile components or significant compounding manipulations, the minimum requirement is quarterly environmental monitoring, as well as additional testing of equipment and personnel.
It is important to note that these are minimum requirements, and facilities may choose to conduct more frequent monitoring in order to ensure the safety and sterility of compounded preparations. The frequency and extent of monitoring should be determined based on a risk assessment specific to the facility and its compounding activities.
Aseptic Enclosures offers a range of environmental monitoring and sampling supplies, including kits for low, medium, and high-risk media, gloved fingertip and surface sampling media plates, and viable air sampling plates. These supplies can help facilities conduct regular testing and maintain compliance with USP <797> guidelines.
Call us today for assistance and supplies! 1-800-418-9289.
