CSPT Environmental Monitoring and Testing

Question 1

According to USP <797>, what is the maximum permitted total particle count (≥0.5 µm) per cubic meter in an ISO Class 5 primary engineering control (PEC)?

Accepted Answer

3,520 particles/m³

Answer

35,200 particles/m³

Answer

352,000 particles/m³

Answer

100,000 particles/m³

Question 2

Which type of sampling device is used to actively collect airborne viable microorganisms for environmental monitoring in a sterile compounding facility?

Accepted Answer

Active air sampler (impaction sampler)

Answer

Anderson impactor

Answer

Settle plate

Answer

Swab contact plate

Question 3

A settle plate (passive air sampling) is exposed in a cleanroom. According to USP <797>, how long should a settle plate be exposed to obtain a valid sample in a PEC?

Accepted Answer

1 hour

Answer

15 minutes

Answer

30 minutes

Answer

4 hours

Question 4

What is the action level for viable surface sampling (contact plates) in an ISO Class 5 PEC, expressed in CFU per contact plate (25 cm²)?

Accepted Answer

0 CFU

Answer

>1 CFU

Answer

>3 CFU

Answer

>5 CFU

Question 5

Which test is performed to verify that a laminar airflow workbench (LAFW) meets ISO Class 5 air quality requirements and that the HEPA filter is intact?

Accepted Answer

DOP/PAO (dispersed oil particulate) aerosol challenge test

Answer

Settle plate culture test

Answer

Endotoxin limulus amebocyte lysate (LAL) test

Answer

Sterility test per USP <71>

Question 6

How frequently must viable environmental monitoring (both air and surface) be performed in ISO Class 5 and ISO Class 7 areas of a Category 2 CSP compounding operation per USP <797>?

Accepted Answer

Monthly

Answer

Daily

Answer

Weekly

Answer

Semi-annually

Question 7

When environmental monitoring results exceed established action levels in a sterile compounding cleanroom, what is the FIRST required step?

Accepted Answer

Identify the source of contamination and perform corrective action before resuming compounding

Answer

Cease all compounding and notify the pharmacist-in-charge immediately

Answer

Increase the frequency of monitoring and document findings

Answer

Recall all CSPs compounded in the affected area within the past 30 days