CSPT Environmental Monitoring and Testing 4 — Questions and Answers
Question 1: When performing viable air sampling in an ISO 5 PEC, which sampling method involves drawing a known volume of air through a nutrient medium to capture microorganisms?
- Settle plate method
- Active air sampling (Correct answer)
- Surface contact sampling
- Glove sampling
Correct answer: Active air sampling
Active air sampling uses an impaction sampler to draw a measured volume of air through or onto a nutrient medium, providing a quantitative count of viable particles.
Question 2: A cleanroom certification report shows particle counts consistently exceeding ISO 7 limits in a buffer room. What is the FIRST corrective action the pharmacy team should take?
- Immediately cease all compounding operations
- Replace the HEPA filters without investigation
- Investigate potential sources such as garbing, traffic, and HVAC issues (Correct answer)
- Reduce the number of personnel in the room
Correct answer: Investigate potential sources such as garbing, traffic, and HVAC issues
The first step is to investigate root causes including personnel garbing practices, traffic patterns, and HVAC performance before implementing corrective actions.
Question 3: Which USP <797> category of compounded sterile preparations has the STRICTEST environmental monitoring frequency requirements due to highest patient risk?
- Category 1 (beyond-use date ≤12 hours)
- Category 2 (beyond-use date >12 hours) (Correct answer)
- Immediate-use preparations
- Radiopharmaceutical preparations
Correct answer: Category 2 (beyond-use date >12 hours)
Category 2 CSPs have longer beyond-use dates and therefore require more rigorous and frequent environmental monitoring because contamination risk accumulates over time.
Question 4: A settle plate exposed in an ISO 7 buffer room for 4 hours shows 15 CFU. According to USP <797> action levels, what should occur?
- No action required; 15 CFU is within limits
- Document the result and continue monitoring
- Investigate the exceedance and implement corrective actions (Correct answer)
- Discard all CSPs compounded during the monitoring period
Correct answer: Investigate the exceedance and implement corrective actions
An action level exceedance requires investigation of the root cause and implementation of corrective actions, along with documentation, per USP <797> requirements.
Question 5: What is the purpose of performing smoke studies (airflow visualization) in a cleanroom environment?
- To test the efficiency of HEPA filters
- To verify unidirectional airflow patterns protect the critical site (Correct answer)
- To measure room air changes per hour
- To calibrate particle counters
Correct answer: To verify unidirectional airflow patterns protect the critical site
Smoke studies visually confirm that airflow sweeps contaminants away from the critical site and that ISO 5 conditions are maintained at the point of compounding.
Question 6: Which organism, if recovered during surface sampling in a sterile compounding area, would be of GREATEST concern due to its resistance to disinfectants and heat?
- Staphylococcus epidermidis
- Bacillus spores (Correct answer)
- Micrococcus luteus
- Candida albicans
Correct answer: Bacillus spores
Bacillus spores are highly resistant to disinfectants and heat, making them particularly dangerous in sterile compounding environments and difficult to eliminate.
Question 7: Under USP <797>, how must environmental monitoring data be trended over time?
- Data must be reviewed only when an exceedance occurs
- Data must be reviewed monthly and trended to identify patterns before action levels are exceeded (Correct answer)
- Data must be sent to the FDA quarterly
- Data must be reviewed annually during certification
Correct answer: Data must be reviewed monthly and trended to identify patterns before action levels are exceeded
USP <797> requires routine trending of environmental monitoring data to detect upward trends that may predict future exceedances before action levels are breached.
CSPT Environmental Monitoring and Testing 4
When performing viable air sampling in an ISO 5 PEC, which sampling method involves drawing a known volume of air through a nutrient medium to capture microorganisms?