What is a primary engineering control (PEC)?

A primary engineering control is a device that creates and maintains an ISO Class 5 environment for compounding sterile preparations. This is crucial in ensuring the safety and sterility of compounded sterile preparations (CSPs), as ISO Class 5 represents an environment that contains fewer than 3,520 particles per cubic meter of air. Such control devices typically include laminar airflow hoods and barrier isolators, which are designed to prevent airborne contaminants from interfering with the compounding process. The ISO Class 5 environment minimizes the risk of microbial contamination during sterile compounding, thereby protecting patient safety and ensuring the efficacy of pharmaceutical preparations.

The other choices pertain to different aspects of pharmaceutical practices but do not accurately define a primary engineering control. For instance, measuring chemical contamination or control methods for hazardous drugs involve other regulations and standards rather than directly providing a sterile environment for compounding. The area designated for non-sterile compounding does not relate to the engineering controls needed for maintaining sterility, which are vital for proper CSP preparation.