CETP CETP Sterile Preparations

Question 1

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

Accepted Answer

To provide a sterile environment by directing HEPA-filtered air across the work surface

Answer

A laminar airflow workbench uses HEPA-filtered unidirectional airflow to maintain an ISO Class 5 sterile environment for preparing sterile products.

Question 2

Which ISO classification is required for the critical zone in sterile compounding?

Accepted Answer

ISO Class 5

Answer

ISO Class 5 (≤3,520 particles ≥0.5 µm per cubic meter) is required for the critical zone where sterile preparations are made.

Question 3

What is the beyond-use date (BUD) for a low-risk compounded sterile preparation stored at room temperature per USP <797>?

Accepted Answer

48 hours

Answer

USP <797> specifies that low-risk compounded sterile preparations have a BUD of 48 hours at controlled room temperature.

Question 4

What is the correct technique for removing air bubbles from a syringe prior to injection?

Accepted Answer

Tap the syringe to collect bubbles at the tip, then expel them

Answer

Tapping the syringe consolidates air bubbles at the tip, which are then expelled to ensure accurate dose delivery.

Question 5

What is the purpose of fingertip sampling in sterile compounding personnel qualification?

Accepted Answer

To evaluate the effectiveness of personnel aseptic technique

Answer

Fingertip sampling tests assess whether compounding personnel are maintaining proper aseptic technique during sterile preparation activities.

CETP - Canadian Entry To Practice Practice Test