What is the required ISO classification for the primary engineering control (PEC) used in preparing Category 2 CSPs?

The primary engineering control (PEC) used in preparing Category 2 Compounded Sterile Preparations (CSPs) is required to be at least ISO Class 5. This classification ensures that the environment maintains a low level of airborne particulate contamination, which is critical for ensuring the sterility of the compounded products. ISO Class 5 indicates that the air cleanliness must have a maximum allowable particle count, specifically allowing no more than 3,520 particles per cubic meter of air that are 0.5 micrometers or larger, which is essential for preparing CSPs that may involve hazardous drugs or other sterile components.

Preparing Category 2 CSPs often involves longer than 12-hour storage periods, necessitating a controlled environment to mitigate risks associated with microbial contamination and other environmental factors. Therefore, adherence to ISO Class 5 standards within the PEC is crucial to achieving the necessary aseptic conditions required for these types of preparations. This classification is foundational for both the safety of the compounded CSPs and the protection of the healthcare professionals involved in the compounding process.