CAOP Sterile Products and Aseptic Technique

Question 1

Which USP chapter governs the compounding of sterile preparations in the United States?

Accepted Answer

USP <797>

Answer

USP <797> establishes standards for the compounding, quality testing, and beyond-use dating of sterile preparations.

Question 2

What is the primary purpose of a laminar airflow workbench (LAFW) in sterile compounding?

Accepted Answer

To provide a particle-free ISO Class 5 environment for aseptic manipulation

Answer

A LAFW provides a continuous stream of HEPA-filtered ISO Class 5 air over the work surface, protecting sterile preparations from microbial and particulate contamination.

Question 3

Which route of administration requires the MOST stringent sterility requirements?

Accepted Answer

Intrathecal

Answer

Intrathecal injections are administered directly into the cerebrospinal fluid, where any contamination or pyrogen can cause life-threatening meningitis or neurotoxicity.

Question 4

What does the term 'beyond-use date' (BUD) mean for a compounded sterile preparation?

Accepted Answer

The date after which the preparation must not be used, based on compounding conditions and storage

Answer

The BUD is assigned by the compounding pharmacist based on USP <797> guidelines, storage conditions, and sterility testing, and differs from a manufacturer's expiration date.

Question 5

A pharmacist is preparing a total parenteral nutrition (TPN) solution. Which electrolyte combination poses the greatest incompatibility risk?

Accepted Answer

Calcium and phosphate

Answer

Calcium phosphate precipitation can form in TPN solutions when calcium and phosphate concentrations exceed solubility limits, potentially causing fatal pulmonary emboli.

CAOP - Competency Assessment of Overseas Pharmacist Practice Test

CAOP - Competency Assessment of Overseas Pharmacist Practice Test

CAOP Sterile Products and Aseptic Technique