Cleanroom Facilities and Equipment Flashcards

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

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

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.

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

Answer: 30 ACPH

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

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

Answer: Cardboard boxes or outer packaging of supply items

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.

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

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

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

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

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

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.

Which of the following best describes the purpose of using a compounding aseptic containment isolator (CACI) for hazardous drug preparation?

Answer: To provide a closed, negatively pressurized work environment that protects both the product and the operator from hazardous drug exposure

A CACI is an isolator designed specifically for hazardous drugs, maintaining negative pressure and barrier containment to protect both the sterile product and the compounder from drug exposure.

Under USP , how often must certification of PECs and the cleanroom environment (HVAC, pressure differentials, airflow) be performed?

Answer: Every 6 months

USP requires that all PECs and the cleanroom environment be certified every 6 months by a qualified certifier to ensure continued compliance with ISO classifications and performance standards.