Environmental Monitoring and Testing Flashcards

A pharmacy installs a new BSC (biological safety cabinet) in the buffer room. Before use for sterile compounding, which certification must be completed first?

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.

When collecting a contact plate sample from a gloved fingertip, the technician should apply the plate to the fingertip with:

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.

A cleanroom's HEPA filter is found to have a pinhole leak during DOP (dispersed oil particulate) testing. What is the appropriate response?

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.

What does a non-viable particle count measure in a sterile compounding environment?

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.

Which of the following personnel behaviors has the GREATEST impact on viable particle counts in an ISO 5 PEC?

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.

What is the recommended sequence for disinfecting surfaces in a laminar airflow workbench (LAFW) before compounding?

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.

A facility's environmental monitoring program identifies Burkholderia cepacia in a surface sample. Why is this finding of particular clinical concern for CSP recipients?

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.