CSPT Environmental Monitoring and Testing 2 — Questions and Answers
Question 1: What is the ISO classification required for the buffer room (secondary engineering control) surrounding a PEC used for Category 2 CSP compounding under USP <797>?
- ISO Class 5
- ISO Class 6
- ISO Class 7 (Correct answer)
- ISO Class 8
Correct answer: ISO Class 7
USP <797> requires that the buffer room (secondary engineering control) maintain at least ISO Class 7 air quality to protect the ISO Class 5 PEC from external contamination.
Question 2: Which of the following best describes a 'dynamic' environmental monitoring condition?
- Testing performed after deep cleaning with no personnel present
- Testing performed while normal compounding activities are occurring (Correct answer)
- Testing performed immediately after HEPA filter replacement
- Testing performed with all equipment powered off
Correct answer: Testing performed while normal compounding activities are occurring
Dynamic (in-use) monitoring is conducted while compounding operations are actively taking place with personnel present, which represents the worst-case scenario and provides the most meaningful data.
Question 3: A contact plate sample taken from the gloved fingertips of a compounding technician shows 2 CFU. According to USP <797> Category 2 action levels, this result requires:
- No action; 2 CFU is within acceptable limits
- Documentation only
- Investigation and corrective action because the gloved fingertip action level is >0 CFU (Correct answer)
- Immediate shutdown of the compounding facility
Correct answer: Investigation and corrective action because the gloved fingertip action level is >0 CFU
USP <797> sets the action level for gloved fingertips at >0 CFU for Category 2 operations; any growth on a fingertip contact plate triggers a mandatory investigation and corrective action.
Question 4: Which organism, commonly found on human skin and frequently detected in environmental monitoring of cleanrooms, is considered an indicator of inadequate garbing or aseptic technique?
- Pseudomonas aeruginosa
- Clostridium difficile
- Staphylococcus epidermidis (Correct answer)
- Bacillus subtilis
Correct answer: Staphylococcus epidermidis
Staphylococcus epidermidis is a coagulase-negative staphylococcus that is a normal flora of human skin; its presence in cleanroom samples indicates personnel are a likely contamination source.
Question 5: For environmental monitoring purposes, what is the key difference between the 'alert level' and 'action level' for microbial contamination?
- Alert level requires immediate shutdown; action level requires documentation only
- Alert level signals a trend that needs attention; action level mandates immediate investigation and corrective action (Correct answer)
- Alert level is set higher than the action level
- Alert and action levels are identical under USP <797>
Correct answer: Alert level signals a trend that needs attention; action level mandates immediate investigation and corrective action
The alert level is a lower threshold indicating a potential drift that warrants increased vigilance, while exceeding the action level is a more serious excursion that mandates immediate investigation and corrective actions.
Question 6: A technician is performing surface sampling using contact plates (RODAC plates). After collection, the plates should be incubated at what temperature range and for how long to recover both bacterial and fungal contaminants?
- 37°C for 24 hours only
- 20-25°C for 5 days, then 30-35°C for 2 days
- 30-35°C for 48-72 hours, then 20-25°C for 5-7 days (Correct answer)
- 4°C for 7 days
Correct answer: 30-35°C for 48-72 hours, then 20-25°C for 5-7 days
A two-stage incubation—first at 30-35°C for 48-72 hours to recover bacteria, then at 20-25°C for 5-7 additional days to recover molds and yeasts—maximizes detection of both organism types.
Question 7: Under USP <797>, non-viable (particle count) environmental monitoring of the ISO Class 5 PEC must be performed at what minimum frequency for a Category 2 compounding operation?
- Daily
- Weekly
- Every 6 months (at certification) (Correct answer)
- Monthly
Correct answer: Every 6 months (at certification)
Non-viable particle count monitoring of the PEC is part of the ISO classification and certification process, which USP <797> requires at least every 6 months for Category 2 operations.
CSPT Environmental Monitoring and Testing 2
What is the ISO classification required for the buffer room (secondary engineering control) surrounding a PEC used for Category 2 CSP compounding under USP ?