CAOP Sterile Products and Aseptic Technique 1 — Questions and Answers
Question 1: Which USP chapter governs the compounding of sterile preparations in the United States?
- USP <795>
- USP <800>
- USP <797> (Correct answer)
- USP <1160>
Correct answer: USP <797>
USP <797> establishes standards for the compounding, quality testing, and beyond-use dating of sterile preparations.
Question 2: What is the primary purpose of a laminar airflow workbench (LAFW) in sterile compounding?
- To sterilize the final product by UV light
- To provide a particle-free ISO Class 5 environment for aseptic manipulation (Correct answer)
- To maintain a negative-pressure environment
- To detect pyrogens in injectable solutions
Correct answer: To provide a particle-free ISO Class 5 environment for aseptic manipulation
A LAFW provides a continuous stream of HEPA-filtered ISO Class 5 air over the work surface, protecting sterile preparations from microbial and particulate contamination.
Question 3: Which route of administration requires the MOST stringent sterility requirements?
- Oral
- Topical
- Intrathecal (Correct answer)
- Ophthalmic drops
Correct answer: Intrathecal
Intrathecal injections are administered directly into the cerebrospinal fluid, where any contamination or pyrogen can cause life-threatening meningitis or neurotoxicity.
Question 4: What does the term 'beyond-use date' (BUD) mean for a compounded sterile preparation?
- The manufacturer's expiration date
- The date after which the preparation must not be used, based on compounding conditions and storage (Correct answer)
- The date the preparation was ordered
- The date by which the preparation must be dispensed
Correct answer: The date after which the preparation must not be used, based on compounding conditions and storage
The BUD is assigned by the compounding pharmacist based on USP <797> guidelines, storage conditions, and sterility testing, and differs from a manufacturer's expiration date.
Question 5: A pharmacist is preparing a total parenteral nutrition (TPN) solution. Which electrolyte combination poses the greatest incompatibility risk?
- Sodium chloride and dextrose
- Calcium and phosphate (Correct answer)
- Magnesium sulfate and potassium chloride
- Sodium acetate and multivitamins
Correct answer: Calcium and phosphate
Calcium phosphate precipitation can form in TPN solutions when calcium and phosphate concentrations exceed solubility limits, potentially causing fatal pulmonary emboli.
Question 6: ISO Class 5 air quality is required in which compounding zone?
- General support area
- Ante-room
- Direct compounding area (DCA) within the primary engineering control (Correct answer)
- Buffer room
Correct answer: Direct compounding area (DCA) within the primary engineering control
ISO Class 5 (≤100 particles ≥0.5 µm per cubic foot) is required at the point of compounding, i.e., within the primary engineering control such as a LAFW or BSC.
CAOP Sterile Products and Aseptic Technique 1
Which USP chapter governs the compounding of sterile preparations in the United States?