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

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?

Accepted Answer

Testing performed while normal compounding activities are occurring

Answer

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:

Accepted Answer

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

Answer

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?

Accepted Answer

Staphylococcus epidermidis

Answer

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?

Accepted Answer

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

Answer

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.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Environmental Monitoring and Testing 2