Compounded Sterile Preparation Technician (CSPT) Practice Exam 2025 - Free Practice Questions and Study Guide.

A Primary Engineering Control (PEC) is specifically defined as a device or room that provides an ISO Class 5 environment. This environment is critical for the compounding of sterile preparations, as it minimizes the risk of contamination by ensuring a highly controlled airflow and air quality that meets stringent standards. ISO Class 5 represents a very clean space, with no more than 3,520 particles per cubic meter for particles 0.5 microns in size or larger, making it suitable for aseptic processes. The effectiveness of a PEC is vital in achieving the necessary conditions to protect both the sterile products and the operators from the potential risks associated with compounding sterile medications.

Other options do not meet the definition of a PEC. An ISO Class 7 environment is not sufficient for sterile compounding, as it does not provide the necessary level of cleanliness. A cleanroom training area does not serve the primary purpose of protecting sterile preparations directly, and a system for managing hazardous substances refers to safety protocols, which are separate from the engineering controls intended for maintaining a sterile environment.