Cleanroom Facilities and Equipment Flashcards

Which ISO classification requires air particle counts of no more than 3,520 particles ≥0.5 µm per cubic meter?

Answer: ISO Class 5

ISO Class 5 permits a maximum of 3,520 particles ≥0.5 µm per cubic meter and is required for the critical zone where sterile preparations are made.

What action should be taken if the primary engineering control (PEC) HEPA filter fails certification during routine testing?

Answer: Immediately cease compounding until the filter is repaired or replaced

USP requires that compounding cease immediately when a PEC fails certification, as sterility of preparations can no longer be assured.

The 'first air' concept in laminar airflow workbenches refers to:

Answer: Air that has passed through the HEPA filter before contacting any surface or critical site

First air is the unobstructed HEPA-filtered air directly from the filter face, which must reach critical sites without being deflected by objects or hands.

How frequently must viable air sampling (active air monitoring) be performed in a cleanroom buffer area under USP ?

Answer: Monthly

USP (2023) requires viable air sampling in the buffer area to be performed at least monthly.

Which of the following best describes the function of the anteroom in a sterile compounding facility?

Answer: It serves as a transition zone where personnel don PPE and maintain a pressure differential buffer

The anteroom is a transitional space used for gowning, hand hygiene, and maintaining a pressure gradient between unclassified and classified areas.

When disinfecting a laminar airflow workbench (LAFW), in which direction should the technician wipe the work surface?

Answer: From back to front in overlapping, side-to-side strokes

Wiping from back to front using overlapping side-to-side strokes moves contamination away from the HEPA filter toward the operator, preventing recontamination of the clean zone.

A compounding technician notices that the pressure differential gauge between the buffer room and anteroom reads a positive value in a hazardous drug compounding suite. This indicates:

Answer: A problem — hazardous drug rooms must maintain negative pressure relative to adjacent areas

Hazardous drug compounding areas must maintain negative pressure (≥0.01–0.03 inch water column) relative to adjacent spaces to contain drug particles and protect personnel.