CSPT Environmental Monitoring and Testing 4

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?

Accepted Answer

Active air sampling

Answer

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?

Accepted Answer

Investigate potential sources such as garbing, traffic, and HVAC issues

Answer

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?

Accepted Answer

Category 2 (beyond-use date >12 hours)

Answer

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?

Accepted Answer

Investigate the exceedance and implement corrective actions

Answer

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?

Accepted Answer

To verify unidirectional airflow patterns protect the critical site

Answer

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.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Environmental Monitoring and Testing 4