Environmental Monitoring and Testing Flashcards

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?

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.

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?

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.

Which USP category of compounded sterile preparations has the STRICTEST environmental monitoring frequency requirements due to highest patient risk?

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.

A settle plate exposed in an ISO 7 buffer room for 4 hours shows 15 CFU. According to USP action levels, what should occur?

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 requirements.

What is the purpose of performing smoke studies (airflow visualization) in a cleanroom environment?

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.

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?

Answer: Bacillus spores

Bacillus spores are highly resistant to disinfectants and heat, making them particularly dangerous in sterile compounding environments and difficult to eliminate.

Under USP , how must environmental monitoring data be trended over time?

Answer: Data must be reviewed monthly and trended to identify patterns before action levels are exceeded

USP requires routine trending of environmental monitoring data to detect upward trends that may predict future exceedances before action levels are breached.