Pharmacy Pharmacy Sterile Compounding 1 — Questions and Answers
Question 1: Which USP chapter provides the standards for sterile compounding in US pharmacies?
- USP <797> (Correct answer)
- USP <795>
- USP <800>
- USP <71>
Correct answer: USP <797>
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?
- To provide an ultra-low particle environment for manipulating sterile products (Correct answer)
- To decontaminate hazardous drug waste
- To store refrigerated CSPs
- To perform sterility testing of finished preparations
Correct answer: To provide an ultra-low particle environment for manipulating sterile products
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?
- Wipe from back to front and side to side using sterile 70% IPA (Correct answer)
- Wipe from front to back using tap water then 70% IPA
- Spray the entire surface with bleach and allow to dry
- Wipe in circular motions with non-sterile isopropyl alcohol
Correct answer: Wipe from back to front and side to side using sterile 70% IPA
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>?
- 12 hours (Correct answer)
- 24 hours
- 30 days
- 14 days
Correct answer: 12 hours
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?
- A set of practices that prevent microbial contamination during product preparation (Correct answer)
- Sterilizing equipment using an autoclave
- Verifying the sterility of finished products by culture
- Filtering CSPs through a 0.22-micron membrane
Correct answer: A set of practices that prevent microbial contamination during product preparation
Aseptic technique refers to the methods and behaviors used during compounding to prevent introduction of microorganisms into a sterile preparation.
Question 6: Which hand hygiene procedure is required before entering a cleanroom for sterile compounding?
- Perform a surgical hand scrub with soap and water followed by application of sterile gloves (Correct answer)
- Use alcohol-based hand sanitizer only
- Wash hands briefly with soap then don gloves immediately
- Clean hands with antiseptic wipe and don gloves without rinsing
Correct answer: Perform a surgical hand scrub with soap and water followed by application of sterile gloves
USP <797> requires a thorough hand and forearm scrub with soap and water for at least 30 seconds, followed by drying with lint-free towels and donning sterile gloves.
Pharmacy Pharmacy Sterile Compounding 1
Which USP chapter provides the standards for sterile compounding in US pharmacies?