NAPLEX QBANK Sterile and Non-sterile Compounding 2 — Questions and Answers
Question 1: Under USP <797>, what is the ISO class requirement for the primary engineering control (PEC) where sterile compounding is performed?
- ISO Class 5 (Correct answer)
- ISO Class 7
- ISO Class 8
- ISO Class 9
Correct answer: ISO Class 5
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?
- Horizontally toward the compounder (Correct answer)
- Downward over the work surface
- Toward the back of the hood
- In a turbulent mixing pattern
Correct answer: Horizontally toward the compounder
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?
- It blocks airflow and creates downstream contamination zones (Correct answer)
- It increases the temperature of the hood
- It reduces the humidity needed for sterility
- It causes the HEPA filter to expire faster
Correct answer: It blocks airflow and creates downstream contamination zones
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?
- At least 6 inches inside (Correct answer)
- At least 1 inch inside
- At the very front edge
- Exactly at the HEPA filter
Correct answer: At least 6 inches inside
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?
- Sterile 70% isopropyl alcohol (Correct answer)
- Sterile water for injection
- 10% povidone-iodine
- 3% hydrogen peroxide
Correct answer: Sterile 70% isopropyl alcohol
Sterile 70% isopropyl alcohol is the standard surface disinfectant for the PEC.
Question 6: What does a hazardous drug (HD) compounding facility require for the primary engineering control under USP <800>?
- A negative-pressure containment device such as a BSC or CACI (Correct answer)
- A positive-pressure horizontal LAFW
- An open bench with surgical masks
- A standard ISO 8 anteroom only
Correct 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.
Question 7: Per USP <797>, what is a beyond-use date (BUD) primarily based on?
- Sterility and stability risk of the preparation (Correct answer)
- The expiration date printed on the source vial only
- The pharmacist's preference
- The patient's insurance coverage period
Correct 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.
NAPLEX QBANK Sterile and Non-sterile Compounding 2
Under USP , what is the ISO class requirement for the primary engineering control (PEC) where sterile compounding is performed?