Is the Containment Secondary Engineering Control (C-SEC) required to be externally vented through HEPA filtration?

The correct answer indicates that the Containment Secondary Engineering Control (C-SEC) does not necessarily need to be externally vented through HEPA filtration.

In the context of USP 800 standards, while C-SEC must be designed to contain hazardous drugs and to ensure adequate protection against exposure, the specific requirement for external venting through HEPA filtration applies only under certain conditions. The primary purpose of C-SEC is to provide a clean environment to minimize exposure to hazardous drugs, but the external venting requirements depend on the types of hazardous drugs being handled, the procedures employed, and whether they require such stringent filtration measures.

The flexibility of C-SEC design allows for a variety of engineering controls that can adequately contain hazardous drugs without mandating HEPA filtration in all instances. Therefore, it is essential to assess the risk associated with the specific drugs being manipulated and apply appropriate controls based on that assessment.

This understanding of the engineering requirements ensures that facilities comply with regulatory standards while still providing safe handling environments for personnel working with hazardous drugs.