Sterile and Non-sterile Compounding Flashcards

Under USP , what is the ISO class requirement for the primary engineering control (PEC) where sterile compounding is performed?

Answer: ISO Class 5

The direct compounding area within the PEC must maintain ISO Class 5 air quality.

A laminar airflow workbench (LAFW) directs HEPA-filtered air in which primary direction during sterile compounding?

Answer: Horizontally toward the compounder

A horizontal LAFW pushes HEPA-filtered air horizontally from the back toward the operator across the work surface.

When using a horizontal laminar airflow hood, why should objects never be placed between the HEPA filter and a sterile item?

Answer: It blocks airflow and creates downstream contamination zones

Objects upstream disrupt first air, creating zones of turbulence and contamination shadows downstream.

What is the recommended minimum distance to work inside a horizontal laminar airflow hood from the outer edge?

Answer: At least 6 inches inside

Working at least 6 inches inside the hood ensures the work is bathed in unidirectional first air.

Which agent is most commonly used to disinfect the work surfaces of a laminar airflow hood before compounding?

Answer: Sterile 70% isopropyl alcohol

Sterile 70% isopropyl alcohol is the standard surface disinfectant for the PEC.

What does a hazardous drug (HD) compounding facility require for the primary engineering control under USP ?

Answer: A negative-pressure containment device such as a BSC or CACI

Hazardous drugs require negative-pressure containment primary engineering controls like a Class II BSC or CACI.

Per USP , what is a beyond-use date (BUD) primarily based on?

Answer: Sterility and stability risk of the preparation

BUDs are assigned based on the risk of microbial contamination and chemical/physical stability of the compounded preparation.