Pharmacy Sterile Compounding Flashcards
6 cards from real Pharmacy practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Pharmacy Sterile Compounding flashcards as text
Which USP chapter provides the standards for sterile compounding in US pharmacies?
Answer: USP
USP establishes legally enforceable standards for the preparation, quality, and handling of compounded sterile preparations (CSPs) in the United States.
What is the purpose of an ISO Class 5 primary engineering control (PEC) in sterile compounding?
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.
What is the correct technique for cleaning a laminar airflow workbench (LAFW) before sterile compounding?
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.
Which beyond-use date (BUD) category applies to a Category 1 CSP stored at room temperature under USP ?
Answer: 12 hours
Under the 2023 USP revision, Category 1 CSPs (prepared without sterility testing) have a maximum BUD of 12 hours at controlled room temperature.
What does 'aseptic technique' mean in sterile compounding?
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.
Which hand hygiene procedure is required before entering a cleanroom for sterile compounding?
Answer: Perform a surgical hand scrub with soap and water followed by application of sterile gloves
USP 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.