CPhT CPhT Sterile Preparations 1 — Questions and Answers
Question 1: What does USP <797> regulate?
- Over-the-counter drug standards
- Pharmaceutical compounding of sterile preparations (Correct answer)
- Controlled substance dispensing
- Nonsterile compounding
Correct answer: Pharmaceutical compounding of sterile preparations
USP <797> establishes standards for pharmaceutical compounding of sterile preparations to ensure patient safety and product quality.
Question 2: What is aseptic technique?
- A method for counting tablets accurately
- Procedures used to prevent microbial contamination of sterile products (Correct answer)
- A calculation method for IV infusions
- A process for labeling medications
Correct answer: Procedures used to prevent microbial contamination of sterile products
Aseptic technique refers to procedures and practices used to prevent microbial contamination when preparing sterile pharmaceutical products.
Question 3: What type of hood is used to prepare chemotherapy (hazardous) drugs?
- Laminar airflow workbench (LAFW)
- Biological safety cabinet (BSC) (Correct answer)
- Standard pharmacy counter
- Horizontal flow hood
Correct answer: Biological safety cabinet (BSC)
A biological safety cabinet (BSC) is used for hazardous drug preparation because it protects both the product and the technician from exposure to toxic agents.
Question 4: What is the purpose of a laminar airflow workbench (LAFW)?
- To store hazardous medications safely
- To provide a sterile environment for preparing non-hazardous IV admixtures (Correct answer)
- To calculate IV flow rates
- To mix oral suspensions
Correct answer: To provide a sterile environment for preparing non-hazardous IV admixtures
A laminar airflow workbench provides a sterile ISO 5 environment by filtering air through HEPA filters, protecting non-hazardous sterile preparations from contamination.
Question 5: What does 'BUD' stand for in sterile compounding?
- Basic Unit Dosing
- Beyond-Use Date (Correct answer)
- Biological Unit Determination
- Base Unit Dilution
Correct answer: Beyond-Use Date
BUD (Beyond-Use Date) is the date and time after which a compounded sterile preparation should not be used, based on storage conditions and sterility requirements.
Question 6: What ISO classification is required for the direct compounding area in sterile preparations?
- ISO 8
- ISO 5 (Correct answer)
- ISO 3
- ISO 10
Correct answer: ISO 5
USP <797> requires an ISO 5 environment for the direct compounding area where sterile products are actually prepared, achieved within a LAFW or BSC.
CPhT CPhT Sterile Preparations 1
What does USP regulate?