CETP CETP Sterile Preparations 1 — Questions and Answers
Question 1: What is the primary purpose of a laminar airflow workbench (LAFW) in sterile compounding?
- To provide a sterile environment by directing HEPA-filtered air across the work surface (Correct answer)
- To maintain controlled temperature for heat-sensitive drugs
- To prevent contamination from light exposure
- To measure the volume of sterile solutions accurately
Correct answer: To provide a sterile environment by directing HEPA-filtered air across the work surface
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?
- ISO Class 3
- ISO Class 5 (Correct answer)
- ISO Class 7
- ISO Class 9
Correct answer: ISO Class 5
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>?
- 48 hours (Correct answer)
- 14 days
- 30 days
- 60 days
Correct answer: 48 hours
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?
- Centrifuge the syringe briefly
- Tap the syringe to collect bubbles at the tip, then expel them (Correct answer)
- Filter the solution through a 0.22-micron membrane
- Heat the syringe gently to dissolve the air
Correct answer: Tap the syringe to collect bubbles at the tip, then expel them
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?
- To verify the pharmacist's handwriting legibility
- To assess glove material integrity
- To evaluate the effectiveness of personnel aseptic technique (Correct answer)
- To measure clean room temperature compliance
Correct answer: To evaluate the effectiveness of personnel aseptic technique
Fingertip sampling tests assess whether compounding personnel are maintaining proper aseptic technique during sterile preparation activities.
Question 6: Which of the following medications is classified as a high-alert medication requiring extra precautions during sterile preparation?
- Normal saline 0.9%
- Concentrated potassium chloride (Correct answer)
- Sterile water for injection
- Dextrose 5% in water
Correct answer: Concentrated potassium chloride
Concentrated potassium chloride is an ISMP high-alert medication that can cause fatal cardiac arrhythmias if administered incorrectly or undiluted.
CETP CETP Sterile Preparations 1
What is the primary purpose of a laminar airflow workbench (LAFW) in sterile compounding?