For low-risk CSPs, what type of PECs are permitted?

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Low-risk compounding sterile preparations (CSPs) can be safely conducted using specific types of primary engineering controls (PECs) that maintain a sterile environment. For this level of risk, the most versatile and compliant PECS include laminar airflow workbenches (LAFWs), biological safety cabinets (BSCs), compounding aseptic isolators (CAIs), and compounding aseptic containment isolators (CACIs).

These PECs help ensure that the compounded medications are not exposed to contaminants during preparation by employing appropriate airflow patterns and filters. Laminar airflow workbenches provide a unidirectional airflow that protects the product, while biological safety cabinets also provide protection for the operator working with potentially hazardous drugs. CAIs and CACIs provide an enclosed sterile environment that minimizes the risk of contamination.

This range of PECs is essential for maintaining compliance with sterility standards in low-risk compounding, effectively balancing safety and efficacy in drug preparation. Other alternatives listed do not offer the same level of protection or compliance with regulations.

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