USP 797 Secondary Engineering
Controls Question and answers already
passed 2025
How frequently should certification of secondary engineering controls occur? -
correct answer ✔Every 6 months
According to USP 797, what is the minimum distance the sink should be from
the PEC in a segregated compounding area? - correct answer ✔1 meter
What can you tell a colleague about relative humidity? - correct answer
✔USP 797 requires maintaining cleanroom relative humidity between 35%
and 65%.
What should you keep in mind about the impact of temperature monitoring in
cleanroom suites? - correct answer ✔USP 797 mandates a temperature of
under 65⁰ F.
What is the minimum air changes per hour that are required for an ISO Class
8 anteroom for nonhazardous compounding? - correct answer ✔20
What is the minimum air changes per hour that are required for an ISO Class
7 buffer room? - correct answer ✔30
Unless a smoke study demonstrates an absence of stagnant airflow where
particulates will accumulate, where does USP 797 require returns to be? -
correct answer ✔Low On the Wall
Controls Question and answers already
passed 2025
How frequently should certification of secondary engineering controls occur? -
correct answer ✔Every 6 months
According to USP 797, what is the minimum distance the sink should be from
the PEC in a segregated compounding area? - correct answer ✔1 meter
What can you tell a colleague about relative humidity? - correct answer
✔USP 797 requires maintaining cleanroom relative humidity between 35%
and 65%.
What should you keep in mind about the impact of temperature monitoring in
cleanroom suites? - correct answer ✔USP 797 mandates a temperature of
under 65⁰ F.
What is the minimum air changes per hour that are required for an ISO Class
8 anteroom for nonhazardous compounding? - correct answer ✔20
What is the minimum air changes per hour that are required for an ISO Class
7 buffer room? - correct answer ✔30
Unless a smoke study demonstrates an absence of stagnant airflow where
particulates will accumulate, where does USP 797 require returns to be? -
correct answer ✔Low On the Wall
