CSPT Sterile Compound Prep Exam Questions & Answers 2026 (1–10)

Question 1

What is the required ISO classification inside a primary engineering control such as a laminar airflow workbench during sterile compounding?

TheoryPractice · Accepted Answer

ISO Class 5. ISO Class 5 is the required air quality classification for the direct compounding environment inside primary engineering controls to minimize particulate contamination during sterile preparation.

Question 2

Which type of primary engineering control should be used when compounding hazardous sterile preparations?

TheoryPractice · Accepted Answer

Biological safety cabinet. A biological safety cabinet or compounding aseptic containment isolator provides both product protection and personnel protection through negative pressure and HEPA-filtered exhaust, making them appropriate for hazardous drug compounding.

Question 3

What is the correct pressure differential relationship between a buffer room and an anteroom when compounding non-hazardous sterile preparations?

TheoryPractice · Accepted Answer

Buffer room positive to anteroom. The buffer room must maintain positive pressure relative to the anteroom to prevent less clean air from entering the cleanest compounding area, protecting the sterile compounding environment.

Question 4

Which component is essential for maintaining ISO Class 5 air quality in a laminar airflow workbench?

TheoryPractice · Accepted Answer

HEPA filter. HEPA (High Efficiency Particulate Air) filters remove 99.97% of particles 0.3 microns or larger, creating the ISO Class 5 environment required for sterile compounding.

Question 5

What is the minimum ISO classification required for an anteroom in a facility performing sterile compounding?

TheoryPractice · Accepted Answer

ISO Class 8. ISO Class 8 is the minimum classification for anterooms, providing a transitional environment between unclassified areas and the ISO Class 7 buffer room.

Question 6

Which type of environmental monitoring detects living microorganisms in the compounding area?

TheoryPractice · Accepted Answer

Viable air sampling. Viable air sampling uses collection media to capture and culture living microorganisms from the air, allowing detection and quantification of microbial contamination.

Question 7

What action should be taken when surface sampling results in a buffer room exceed established action levels?

TheoryPractice · Accepted Answer

Clean, disinfect, and retest the area. When environmental monitoring results exceed action levels, the area must be cleaned, disinfected, and retested to ensure it returns to acceptable microbial limits before resuming compounding.

Question 8

Which type of biological safety cabinet provides both product and personnel protection while venting HEPA-filtered air back into the room?

TheoryPractice · Accepted Answer

Class II Type A. Class II Type A biological safety cabinets provide protection for both personnel and product, recirculating HEPA-filtered air back into the laboratory after removing particulates and potential contaminants.

Question 9

How frequently must non-viable particle sampling be performed in an ISO Class 5 primary engineering control?

TheoryPractice · Accepted Answer

At least every six months. According to USP standards, non-viable particle sampling in ISO Class 5 environments must be performed at least every six months to verify air quality certification and proper HEPA filter function.

Question 10

What is the primary purpose of a segregated compounding area?

TheoryPractice · Accepted Answer

To allow limited low-risk compounding when a full cleanroom is not available. A segregated compounding area contains ISO Class 5 primary engineering controls in a room that does not meet ISO Class 7 or 8 requirements, limited to compounding low-risk CSPs with 12-hour or less beyond use dates.

CSPT Sterile Compound Prep Exam Questions & Answers 2026 (1–10)

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