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Cleanroom Facilities and Equipment Flashcards

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

Read the first 6 Cleanroom Facilities and Equipment flashcards as text
  1. What is the required ISO classification for the buffer area in a sterile compounding facility?

    Answer: ISO Class 7

    The buffer area must maintain ISO Class 7 air quality conditions per USP 797.

  2. How often should HEPA filters in a laminar airflow workbench be certified?

    Answer: Every 6 months

    HEPA filters in LAFWs and other PECs must be certified at least every 6 months.

  3. What is the primary difference between a horizontal LAFW and a vertical LAFW?

    Answer: In a horizontal LAFW air flows back to front; in a vertical LAFW air flows top to bottom

    The key difference is airflow direction: horizontal LAFWs push air from the back wall toward the technician, while vertical LAFWs direct air downward from the top.

  4. What is the purpose of a pressure differential between the buffer area and the ante-area?

    Answer: To prevent less clean air from flowing into the cleaner buffer area

    A positive pressure differential ensures air flows from the cleaner buffer area outward to the less clean ante-area, preventing contamination.

  5. Which cleaning agent is recommended for daily cleaning of the interior surfaces of a LAFW?

    Answer: Sterile 70% isopropyl alcohol

    Sterile 70% IPA is the standard agent for daily cleaning of LAFW interior surfaces.

  6. What does a Biological Safety Cabinet (BSC) provide that a standard horizontal LAFW does not?

    Answer: Personnel protection through inward airflow at the front opening

    A BSC provides both product protection and personnel protection through inward airflow at the front opening and downward HEPA-filtered air.

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