What is the appropriate environment for low-risk sterile compounding?

Low-risk sterile compounding must be performed in an environment that minimizes the risk of contamination and maintains the quality of the sterile products being prepared. The correct standard for low-risk sterile compounding is an ISO class 5 environment or better.

ISO class 5 provides a controlled area with a maximum allowable particle count of 3,520 particles per cubic meter for particles equal to or greater than 0.5 micrometers in size. This ensures that there is minimal exposure to airborne contaminants during the compounding process, which is crucial because the products being prepared must be sterile.

According to the United States Pharmacopeia (USP) guidelines, low-risk compounding can occur in a Class 100 cleanroom or an equivalently clean environment. This standard is upheld to ensure patient safety and product integrity, making ISO class 5 or better the appropriate setting for this activity.

Other options, such as ISO class 3 or 4, do not provide the necessary level of cleanliness required for low-risk compounding, as they are designed for areas where higher levels of particle contamination can be present. ISO class 6, while better than higher classes, also does not meet the stringent requirements set forth for low-risk sterile preparations. Thus,