Pharmacy Pharmacy Sterile Compounding

Question 1

Which USP chapter provides the standards for sterile compounding in US pharmacies?

Accepted Answer

USP <797>

Answer

USP <797> establishes legally enforceable standards for the preparation, quality, and handling of compounded sterile preparations (CSPs) in the United States.

Question 2

What is the purpose of an ISO Class 5 primary engineering control (PEC) in sterile compounding?

Accepted Answer

To provide an ultra-low particle environment for manipulating sterile products

Answer

An ISO Class 5 PEC (such as a laminar airflow workbench or biological safety cabinet) maintains a controlled environment with no more than 3,520 particles ≥0.5 µm per cubic meter.

Question 3

What is the correct technique for cleaning a laminar airflow workbench (LAFW) before sterile compounding?

Accepted Answer

Wipe from back to front and side to side using sterile 70% IPA

Answer

The LAFW should be cleaned from the back to the front (away from the HEPA filter) using overlapping side-to-side strokes with sterile 70% isopropyl alcohol to avoid recontamination.

Question 4

Which beyond-use date (BUD) category applies to a Category 1 CSP stored at room temperature under USP <797>?

Accepted Answer

12 hours

Answer

Under the 2023 USP <797> revision, Category 1 CSPs (prepared without sterility testing) have a maximum BUD of 12 hours at controlled room temperature.

Question 5

What does 'aseptic technique' mean in sterile compounding?

Accepted Answer

A set of practices that prevent microbial contamination during product preparation

Answer

Aseptic technique refers to the methods and behaviors used during compounding to prevent introduction of microorganisms into a sterile preparation.

Pharmacy Practice Test

Pharmacy Practice Test

Pharmacy Pharmacy Sterile Compounding