NAPLEX QBANK Sterile and Non-sterile Compounding 2

Question 1

Under USP <797>, what is the ISO class requirement for the primary engineering control (PEC) where sterile compounding is performed?

Accepted Answer

ISO Class 5

Answer

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

Question 2

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

Accepted Answer

Horizontally toward the compounder

Answer

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

Question 3

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

Accepted Answer

It blocks airflow and creates downstream contamination zones

Answer

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

Question 4

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

Accepted Answer

At least 6 inches inside

Answer

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

Question 5

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

Accepted Answer

Sterile 70% isopropyl alcohol

Answer

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

NAPLEX QBANK Practice Test