CSPT Cleanroom Facilities and Equipment 5 — Questions and Answers
Question 1: A biological safety cabinet (BSC) Class II Type A2 used for hazardous drug compounding differs from a standard LAFW primarily because it:
- Recirculates filtered air internally and exhausts a portion to the outside, protecting both product and operator (Correct answer)
- Provides only product protection with no operator protection
- Operates under positive pressure to protect the product from room air
- Uses UV light instead of HEPA filtration for sterilization
Correct 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.
Question 2: The required minimum air changes per hour (ACPH) for an ISO Class 7 buffer room is:
- 30 ACPH (Correct answer)
- 10 ACPH
- 20 ACPH
- 50 ACPH
Correct answer: 30 ACPH
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?
- Cardboard boxes or outer packaging of supply items (Correct answer)
- Sterile syringes in their inner packaging
- Alcohol-disinfected vials
- IPA-wiped ampules
Correct 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.
Question 4: Environmental monitoring data shows persistent Bacillus species colonies on settle plates in the buffer room. The most appropriate next step is:
- Perform a root-cause investigation, re-clean all surfaces, and resample before resuming compounding (Correct answer)
- Increase the frequency of garbing and continue normal compounding operations
- Replace only the settle plates and repeat sampling at the next scheduled interval
- Report the finding but take no action since Bacillus is non-pathogenic
Correct 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.
Question 5: A compounding technician accidentally bumps the HEPA filter face while working inside the LAFW. The correct response is to:
- Stop work, re-disinfect all surfaces and materials in the LAFW, and allow adequate purge time before resuming (Correct answer)
- Continue working since the HEPA filter is self-cleaning
- Wipe the filter face with 70% IPA and immediately resume compounding
- Discard all prepared compounds and shut down the LAFW for the rest of the day
Correct 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.
Question 6: Which of the following best describes the purpose of using a compounding aseptic containment isolator (CACI) for hazardous drug preparation?
- To provide a closed, negatively pressurized work environment that protects both the product and the operator from hazardous drug exposure (Correct answer)
- To eliminate the need for cleanroom facilities entirely when working with hazardous drugs
- To allow compounding of hazardous drugs in an unclassified room without any PPE requirements
- To provide ISO Class 7 air quality inside a standard pharmacy dispensing area
Correct 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.
Question 7: Under USP <797>, how often must certification of PECs and the cleanroom environment (HVAC, pressure differentials, airflow) be performed?
- Every 6 months (Correct answer)
- Annually
- Monthly
- Every 3 months
Correct answer: Every 6 months
USP <797> 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.
CSPT Cleanroom Facilities and Equipment 5
A biological safety cabinet (BSC) Class II Type A2 used for hazardous drug compounding differs from a standard LAFW primarily because it: