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Sterile Products and Aseptic Technique Flashcards

6 cards from real CAOP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. Which USP chapter governs the compounding of sterile preparations in the United States?

    Answer: USP

    USP establishes standards for the compounding, quality testing, and beyond-use dating of sterile preparations.

  2. What is the primary purpose of a laminar airflow workbench (LAFW) in sterile compounding?

    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.

  3. Which route of administration requires the MOST stringent sterility requirements?

    Answer: Intrathecal

    Intrathecal injections are administered directly into the cerebrospinal fluid, where any contamination or pyrogen can cause life-threatening meningitis or neurotoxicity.

  4. What does the term 'beyond-use date' (BUD) mean for a compounded sterile preparation?

    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 guidelines, storage conditions, and sterility testing, and differs from a manufacturer's expiration date.

  5. A pharmacist is preparing a total parenteral nutrition (TPN) solution. Which electrolyte combination poses the greatest incompatibility risk?

    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.

  6. ISO Class 5 air quality is required in which compounding zone?

    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.