CSPT Environmental Monitoring and Testing 2

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>?

Accepted Answer

ISO Class 7

Answer

ISO Class 5

Answer

ISO Class 6

Answer

ISO Class 8

Question 2

Which of the following best describes a 'dynamic' environmental monitoring condition?

Accepted Answer

Testing performed while normal compounding activities are occurring

Answer

Testing performed after deep cleaning with no personnel present

Answer

Testing performed immediately after HEPA filter replacement

Answer

Testing performed with all equipment powered off

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:

Accepted Answer

Investigation and corrective action because the gloved fingertip action level is >0 CFU

Answer

No action; 2 CFU is within acceptable limits

Answer

Documentation only

Answer

Immediate shutdown of the compounding facility

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?

Accepted Answer

Staphylococcus epidermidis

Answer

Pseudomonas aeruginosa

Answer

Clostridium difficile

Answer

Bacillus subtilis

Question 5

For environmental monitoring purposes, what is the key difference between the 'alert level' and 'action level' for microbial contamination?

Accepted Answer

Alert level signals a trend that needs attention; action level mandates immediate investigation and corrective action

Answer

Alert level requires immediate shutdown; action level requires documentation only

Answer

Alert level is set higher than the action level

Answer

Alert and action levels are identical under USP <797>

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?

Accepted Answer

30-35°C for 48-72 hours, then 20-25°C for 5-7 days

Answer

37°C for 24 hours only

Answer

20-25°C for 5 days, then 30-35°C for 2 days

Answer

4°C for 7 days

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?

Accepted Answer

Every 6 months (at certification)

Answer

Daily

Answer

Weekly

Answer

Monthly