CSPT Environmental Monitoring and Testing 5 — Questions and Answers
Question 1: A pharmacy installs a new BSC (biological safety cabinet) in the buffer room. Before use for sterile compounding, which certification must be completed first?
- USP <71> sterility testing of sample preparations
- Certification per NSF/ANSI 49 by a qualified certifier (Correct answer)
- A 30-day environmental monitoring baseline period
- OSHA hazardous drug handling inspection
Correct answer: Certification per NSF/ANSI 49 by a qualified certifier
A new BSC must be certified per NSF/ANSI 49 by a qualified certifier to confirm HEPA filter integrity, airflow velocity, and containment before it can be used for compounding.
Question 2: When collecting a contact plate sample from a gloved fingertip, the technician should apply the plate to the fingertip with:
- Firm rolling pressure across all five fingers simultaneously
- Light, consistent pressure for approximately 5–10 seconds per finger (Correct answer)
- A single firm press for less than one second
- Pressure held for at least 60 seconds to ensure transfer
Correct answer: Light, consistent pressure for approximately 5–10 seconds per finger
Consistent, moderate pressure for 5–10 seconds per finger ensures adequate contact between the agar and the glove surface for reliable microbial recovery.
Question 3: A cleanroom's HEPA filter is found to have a pinhole leak during DOP (dispersed oil particulate) testing. What is the appropriate response?
- Patch the filter with approved sealant and retest immediately
- Repair or replace the filter, then re-certify before resuming compounding (Correct answer)
- Continue operations at reduced capacity until a replacement arrives
- Document the defect and schedule repair at the next quarterly certification
Correct answer: Repair or replace the filter, then re-certify before resuming compounding
A compromised HEPA filter must be repaired or replaced and the area re-certified before compounding can safely resume to ensure ISO classification is maintained.
Question 4: What does a non-viable particle count measure in a sterile compounding environment?
- The number of living microorganisms per cubic meter of air
- The total number of particles of specified sizes per cubic meter regardless of viability (Correct answer)
- The rate of HEPA filter particle removal efficiency
- The concentration of hazardous drug aerosolization
Correct answer: The total number of particles of specified sizes per cubic meter regardless of viability
Non-viable particle counters measure the total number of airborne particles (both living and non-living) of specified sizes to confirm ISO classification is maintained.
Question 5: Which of the following personnel behaviors has the GREATEST impact on viable particle counts in an ISO 5 PEC?
- Wearing two pairs of gloves instead of one
- Excessive movement and talking during compounding (Correct answer)
- Using sterile 70% IPA instead of sterile 70% ethanol
- Positioning the product in the rear of the PEC work zone
Correct answer: Excessive movement and talking during compounding
Excessive movement and talking generate significant particle shedding from personnel, which is the primary source of viable contamination in cleanroom environments.
Question 6: What is the recommended sequence for disinfecting surfaces in a laminar airflow workbench (LAFW) before compounding?
- Sides first, then the work surface, then the back wall
- Back wall first, then sides, then the work surface working front to back (Correct answer)
- Work surface first, then sides, then the back wall
- Back wall first, then work surface front to back, then sides
Correct answer: Back wall first, then sides, then the work surface working front to back
Disinfection in a LAFW should proceed from back to front and top to bottom so that contaminants are moved toward the technician and away from the critical zone, following airflow direction.
Question 7: A facility's environmental monitoring program identifies Burkholderia cepacia in a surface sample. Why is this finding of particular clinical concern for CSP recipients?
- It causes rapid HEPA filter degradation
- It is an intrinsically resistant waterborne pathogen that can cause severe infections, especially in immunocompromised patients (Correct answer)
- It indicates the disinfectant concentration is too high
- It is commonly found in healthy skin flora and rarely pathogenic
Correct answer: It is an intrinsically resistant waterborne pathogen that can cause severe infections, especially in immunocompromised patients
Burkholderia cepacia is a waterborne organism with intrinsic resistance to many disinfectants and antibiotics, posing severe infection risk particularly to immunocompromised or cystic fibrosis patients.
CSPT Environmental Monitoring and Testing 5
A pharmacy installs a new BSC (biological safety cabinet) in the buffer room.
Before use for sterile compounding, which certification must be completed first?