What class of air quality must the Direct Compounding Area maintain?

The Direct Compounding Area (DCA) in a sterile compounding environment must maintain an air quality of ISO Class 5. This standard is crucial because it ensures that the area where sterile products are prepared has a minimal level of particulates, microorganisms, and contaminants, thereby protecting the integrity of the compounded products.

ISO Class 5 specifies that the maximum allowable particle count is 3,520 particles per cubic meter for particles 0.5 micrometers and larger. This low level of particulate matter is necessary for preventing contamination, particularly in areas where procedures such as the preparation of intravenous medications occur, which are particularly sensitive to contamination.

Maintaining this environment supports the overall safety and efficacy of sterile compounding practices, as it is essential to prevent infections or adverse reactions that could occur from exposure to contaminants during the compounding process.