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

Ante-room relative to the buffer room

Answer

Hazardous drug compounding negative-pressure room

Answer

Pass-through cabinet relative to the buffer room

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

Only after a major cleaning or disinfection event

Answer

As part of routine ongoing monitoring alongside dynamic testing

Answer

Only when dynamic testing exceeds action levels

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

To confirm the room achieves ISO Class 5 particle counts

Answer

To test personnel garbing compliance

Answer

To measure the air change rate per hour in the buffer room

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

Positive pressure (≥0.02-inch water column)

Answer

Neutral pressure

Answer

Negative pressure (≥0.05-inch water column)

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

Sabouraud dextrose agar (SDA)

Answer

MacConkey agar

Answer

Blood agar (BAP)

Question 6

Under USP <797>, how often must the pressure differential between the buffer room and ante-room be monitored and documented?

Accepted Answer

Continuously via a magnehelic gauge with daily log review

Answer

Weekly

Answer

Monthly, at the time of viable environmental monitoring

Answer

At each certification event (every 6 months)

Question 7

After identifying mold contamination during environmental monitoring, what is the recommended approach for decontaminating the affected surfaces in a sterile compounding cleanroom?

Accepted Answer

Sporicidal agent (e.g., bleach solution or hydrogen peroxide vapor) followed by 70% IPA

Answer

70% isopropyl alcohol (IPA) alone is sufficient for mold remediation

Answer

Quaternary ammonium compound followed by steam cleaning

Answer

Ultraviolet light irradiation only