Which ISO classification is required for the primary engineering control (PEC) in a Low Risk CSP area?

In a Low Risk Compounded Sterile Preparations (CSP) area, the primary engineering control (PEC) must maintain a sterile environment to ensure the safety of the compounded products. ISO classifications specify the maximum allowable particulate counts in air, which directly influences the cleanliness of the environment in which sterile preparations are made.

ISO 5 is the required classification for the PEC in a Low Risk CSP area. This means the air within the PEC must have no more than 3,520 particles per cubic meter that are 0.5 micrometers or larger, creating an environment where the risk of contamination is minimized during the preparation of sterile products. Maintaining an ISO 5 environment within the PEC is critical for ensuring the sterility of compounded medications in low risk CSP practices, as it prevents the introduction of contaminants that could affect patient safety.

Other classifications, such as ISO 7, ISO 8, and ISO 6, do not meet the stringent requirements necessary for the PEC in a Low Risk CSP scenario, as they allow for higher levels of particulate contamination, thus compromising the safety and efficacy of the sterile preparations being compounded.