What environment is required for preparing low-risk CSPs?

Preparing low-risk compounded sterile preparations (CSPs) requires an environment that maintains a certain level of cleanliness and sterility to ensure the safety and efficacy of the final product. Specifically, an ISO Class 5 environment is mandated for the preparation of low-risk CSPs.

ISO Class 5 indicates a controlled environment in which the air cleanliness is sufficiently high, containing no more than 3,520 particles of 0.5 micron or larger per cubic meter of air. This level of air cleanliness is essential for preventing microbial or particulate contamination during the compounding process. In an ISO Class 5 environment, the use of laminar flow hoods or vertical airflow workstations helps maintain this sterile space, which is critical for patient safety, especially when the compounded products are intended for intravenous use or other routes that bypass the body’s natural defenses.

Other environments listed, such as room temperature, cold storage, and outdoor areas, do not meet the stringent requirements needed for the preparation of low-risk CSPs. Room temperature does not specify air quality, cold storage limits the types of CSPs that can be prepared, and outdoor areas cannot provide the sterile environment necessary for compounding. Ensuring that compounding occurs in an ISO Class 5 environment is fundamental