CSPT Cleanroom Facilities and Equipment 5

Question 1

A biological safety cabinet (BSC) Class II Type A2 used for hazardous drug compounding differs from a standard LAFW primarily because it:

Accepted Answer

Recirculates filtered air internally and exhausts a portion to the outside, protecting both product and operator

Answer

A Class II Type A2 BSC recirculates approximately 70% of air through a HEPA filter within the cabinet and exhausts 30% to the outside, providing both product and personnel protection.

Question 2

The required minimum air changes per hour (ACPH) for an ISO Class 7 buffer room is:

Accepted Answer

30 ACPH

Answer

USP <797> requires a minimum of 30 ACPH of HEPA-filtered air for an ISO Class 7 buffer room to maintain proper air quality.

Question 3

Which of the following items is NOT permitted to be brought directly into the ISO Class 5 critical zone of a laminar airflow workbench?

Accepted Answer

Cardboard boxes or outer packaging of supply items

Answer

Cardboard and outer packaging harbor high levels of particles and microorganisms and must never enter the critical zone or buffer area; only the inner sterile packaging may be introduced.

Question 4

Environmental monitoring data shows persistent Bacillus species colonies on settle plates in the buffer room. The most appropriate next step is:

Accepted Answer

Perform a root-cause investigation, re-clean all surfaces, and resample before resuming compounding

Answer

Persistent environmental monitoring failures require a documented root-cause investigation, remediation (including thorough cleaning and disinfection), and verification resampling before compounding resumes.

Question 5

A compounding technician accidentally bumps the HEPA filter face while working inside the LAFW. The correct response is to:

Accepted Answer

Stop work, re-disinfect all surfaces and materials in the LAFW, and allow adequate purge time before resuming

Answer

Touching the HEPA filter may disrupt airflow patterns; all surfaces must be re-disinfected and the unit allowed to purge for a sufficient time before compounding resumes.

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT - Compounded Sterile Preparation Technician Practice Test

CSPT Cleanroom Facilities and Equipment 5