CSPT Environmental Monitoring and Testing 3

Question 1

Which area of a sterile compounding suite must maintain a positive pressure differential relative to adjacent less-clean areas?

Accepted Answer

Buffer room relative to the ante-room and general pharmacy

Answer

The buffer room (ISO Class 7) must be maintained at positive pressure relative to the ante-room and general pharmacy to prevent contaminated air from flowing into the cleanest compounding area.

Question 2

When must environmental monitoring be performed 'at rest' (static conditions) in a cleanroom?

Accepted Answer

Only during initial ISO classification and after facility renovations

Answer

Static (at-rest) testing is primarily used for initial ISO classification and after significant changes such as renovations, HEPA filter changes, or major equipment installation, rather than as part of routine monitoring.

Question 3

What is the primary purpose of performing a smoke visualization (airflow visualization) study in a laminar airflow workbench?

Accepted Answer

To verify that unidirectional airflow properly sweeps the critical work zone without turbulence or dead spots

Answer

Smoke visualization studies confirm that the HEPA-filtered unidirectional airflow sweeps the critical zone cleanly, identifying any turbulence, recirculation zones, or dead spots that could allow contamination.

Question 4

A compounding facility is using a biological safety cabinet (BSC) Class II Type A2 for hazardous drug compounding. What pressure relationship must the hazardous drug compounding room maintain relative to adjacent spaces?

Accepted Answer

Negative pressure (≥0.01-inch water column)

Answer

Rooms used for hazardous drug compounding must be maintained at negative pressure (at least 0.01-inch water column) relative to adjacent spaces to contain any drug vapors or aerosols within the compounding area.

Question 5

Which culture media is most commonly used in contact plates and settle plates for viable environmental monitoring of pharmaceutical cleanrooms because it supports the growth of a broad range of bacteria and fungi?

Accepted Answer

Tryptic soy agar (TSA)

Answer

Tryptic soy agar (TSA) is the standard general-purpose medium for pharmaceutical environmental monitoring because it supports growth of a wide range of bacteria and many fungi under standard incubation conditions.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Environmental Monitoring and Testing 3