TheoryCSPT Sterile Compounding Exam Practice Questions
Free CSPT Sterile Compounding Exam practice questions with answers and plain-English explanations. Browse the PDF, video and online mock test.
CSPT Sterile Compounding Exam Questions
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Q1What is the required ISO classification inside a primary engineering control such as a laminar airflow workbench during sterile compounding?
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✓ Correct 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.
Q2Which type of primary engineering control should be used when compounding hazardous sterile preparations?
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✓ Correct 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.
Q3What is the correct pressure differential relationship between a buffer room and an anteroom when compounding non-hazardous sterile preparations?
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✓ Correct 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.
Q4Which component is essential for maintaining ISO Class 5 air quality in a laminar airflow workbench?
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✓ Correct 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.
Q5What is the minimum ISO classification required for an anteroom in a facility performing sterile compounding?
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✓ Correct 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.
Q6Which type of environmental monitoring detects living microorganisms in the compounding area?
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✓ Correct 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.
Q7What action should be taken when surface sampling results in a buffer room exceed established action levels?
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✓ Correct 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.
Q8Which type of biological safety cabinet provides both product and personnel protection while venting HEPA-filtered air back into the room?
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✓ Correct 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.
Q9How frequently must non-viable particle sampling be performed in an ISO Class 5 primary engineering control?
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✓ Correct 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.
Q10What is the primary purpose of a segregated compounding area?
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✓ Correct 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.
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