CAOP Sterile Products and Aseptic Technique 2 — Questions and Answers
Question 1: Which type of biological safety cabinet (BSC) is used when preparing hazardous drugs?
- Class I BSC
- Class II Type A2 BSC
- Horizontal laminar airflow workbench
- Class II Type B2 BSC (Correct answer)
Correct answer: Class II Type B2 BSC
A Class II Type B2 BSC is total-exhaust and externally vented, providing both product and personnel protection required for hazardous drug compounding.
Question 2: What is the significance of endotoxin testing (LAL test) for parenteral products?
- It confirms sterility by detecting bacteria
- It detects bacterial endotoxins (pyrogens) that can cause fever and septic shock (Correct answer)
- It measures the pH of the solution
- It verifies preservative concentration
Correct answer: It detects bacterial endotoxins (pyrogens) that can cause fever and septic shock
The Limulus Amebocyte Lysate (LAL) test detects gram-negative bacterial endotoxins that can cause pyrogenic reactions even if the product is sterile.
Question 3: Which hand hygiene step is CRITICAL before gowning for sterile compounding?
- Applying hand lotion
- Performing a surgical hand scrub with an antimicrobial agent for at least 30 seconds (Correct answer)
- Rinsing hands with sterile water only
- Wearing double gloves without washing
Correct answer: Performing a surgical hand scrub with an antimicrobial agent for at least 30 seconds
A thorough antiseptic hand scrub removes transient microorganisms and reduces resident flora before donning sterile gloves for aseptic compounding.
Question 4: A pharmacist notices visible particles in a prepared IV bag. The CORRECT action is to:
- Filter the solution before dispensing
- Warm the bag to dissolve the particles
- Quarantine and discard the preparation, then investigate the cause (Correct answer)
- Dispense with a warning label
Correct answer: Quarantine and discard the preparation, then investigate the cause
Visible particulate matter indicates contamination or incompatibility; the preparation must be discarded and the root cause investigated to prevent patient harm.
Question 5: What is the function of a 0.22-micron filter used in IV admixture preparation?
- Removes endotoxins from solutions
- Sterilizes the solution by removing bacteria and particulates ≥0.22 µm (Correct answer)
- Removes air bubbles from the IV line
- Concentrates the drug before administration
Correct answer: Sterilizes the solution by removing bacteria and particulates ≥0.22 µm
A 0.22-micron sterilizing filter removes bacteria, fungi, and particulate matter, providing terminal sterilization for preparations that cannot be autoclaved.
Question 6: According to USP <797>, which condition requires Category 2 BUD assignment for a compounded sterile preparation?
- Prepared in ISO Class 5 conditions within 1 hour of administration
- Prepared from non-sterile components or requiring extended storage (Correct answer)
- Prepared from sterile commercial products and administered immediately
- Any preparation containing preservatives
Correct answer: Prepared from non-sterile components or requiring extended storage
Category 2 CSPs involve more complex conditions, including use of non-sterile starting materials or extended storage, requiring more rigorous sterility testing and shorter BUDs.
CAOP Sterile Products and Aseptic Technique 2
Which type of biological safety cabinet (BSC) is used when preparing hazardous drugs?