CSPT Cleanroom Facilities and Equipment 4

Question 1

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

Accepted Answer

ISO Class 5

Answer

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.

Question 2

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

Accepted Answer

Immediately cease compounding until the filter is repaired or replaced

Answer

USP <797> requires that compounding cease immediately when a PEC fails certification, as sterility of preparations can no longer be assured.

Question 3

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

Accepted Answer

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

Answer

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.

Question 4

How frequently must viable air sampling (active air monitoring) be performed in a cleanroom buffer area under USP <797>?

Accepted Answer

Monthly

Answer

USP <797> (2023) requires viable air sampling in the buffer area to be performed at least monthly.

Question 5

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

Accepted Answer

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

Answer

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

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Cleanroom Facilities and Equipment 4