CSPT CSPT - Compounded Sterile Preparation Technician Infection Control and Microbiology Questions and Answers 2 — Questions and Answers
Question 1: What is the primary purpose of environmental monitoring in a sterile compounding facility?
- To detect microbial contamination in the compounding environment (Correct answer)
- To measure only temperature and humidity
- To verify equipment calibration intervals
- To track individual technician performance scores
Correct answer: To detect microbial contamination in the compounding environment
Environmental monitoring identifies microbial contamination trends in the air and on surfaces so corrective actions can be taken before products are affected.
Question 2: Which ISO classification represents the most stringent (cleanest) air quality standard used in sterile compounding?
- ISO 5 (Correct answer)
- ISO 7
- ISO 8
- ISO 6
Correct answer: ISO 5
ISO 5 permits no more than 3,520 particles ≥0.5 microns per cubic meter and is required for the critical zone where products are compounded.
Question 3: Active air sampling in a cleanroom is used to measure:
- Colony-forming units (CFUs) per cubic meter of air (Correct answer)
- Total particle counts per cubic foot of air
- Temperature gradients across the room
- Relative humidity at multiple sensor points
Correct answer: Colony-forming units (CFUs) per cubic meter of air
Active air samplers draw a known volume of air over culture media to quantify viable microbial counts expressed as CFUs per cubic meter.
Question 4: Glove fingertip sampling (fingertip testing) is performed to:
- Verify that personnel gloving and gowning technique does not introduce contamination (Correct answer)
- Test the sterility of compounded end-products
- Check HEPA filter efficiency
- Monitor pressure differential between rooms
Correct answer: Verify that personnel gloving and gowning technique does not introduce contamination
Fingertip testing checks whether the technician's gloves carry microbial contamination after gowning, confirming that hand hygiene and gloving procedures were effective.
Question 5: What is the correct cleaning progression when disinfecting a sterile compounding suite?
- Anteroom → buffer room → ISO 5 area (least to most critical) (Correct answer)
- ISO 5 area → buffer room → anteroom (most to least critical)
- Buffer room → anteroom → ISO 5 area
- ISO 5 area → anteroom → buffer room
Correct answer: Anteroom → buffer room → ISO 5 area (least to most critical)
Cleaning should proceed from least critical (anteroom) to most critical (ISO 5 zone) to avoid tracking contamination into cleaner areas.
Question 6: When environmental monitoring results exceed established action levels, the correct initial response is to:
- Investigate the root cause, re-clean, and retest the area before resuming compounding (Correct answer)
- Continue compounding but document the exceedance in the log
- Discard all products compounded that day without investigation
- Immediately replace all HEPA filters
Correct answer: Investigate the root cause, re-clean, and retest the area before resuming compounding
USP <797> requires a documented investigation and remediation before compounding resumes when action levels are exceeded.
CSPT CSPT - Compounded Sterile Preparation Technician Infection Control and Microbiology Questions and Answers 2
What is the primary purpose of environmental monitoring in a sterile compounding facility?