USP 797 Secondary Engineering
Controls Question and answers
Match the description of the direction of the airflow to the type of airflow. - ANS -- 1) ISO
Class 7 or better - Buffer room
2) ISO Class 7 used to perform hand hygiene and garbing - Anteroom serving HD buffer
room
3)ISO Class 8 used to perform hand hygiene and garbing - Anteroom serving
nonhazardous buffer room
4) Dedicated area into which a PEC is placed - Segregated compounding area
Which of the following tests is not required during certification of secondary engineering
controls? - ANS -- Moisture uniformity testing
Regardless of the type (waist high or full height), only one door of a pass through may
be opened at a time. - ANS -- True
A buffer room has only one LAFW. If the LAFW contributes 10 ACPH to the room, then
what is the minimum ACPH that the room must deliver to meet the USP Chapter 797
requirement? Write the answer numerically. - ANS -- 20
USP 797 (2022) specifies that a minimum of 20 ACPH are required for ISO Class 8
anterooms. - ANS -- True
Which of the following should be AVOIDED in buffer and anteroom designs? More than
one answer is correct, so select all that apply. - ANS -- Cabinets
Exposed pipes under sink
Large door jambs
Controls Question and answers
Match the description of the direction of the airflow to the type of airflow. - ANS -- 1) ISO
Class 7 or better - Buffer room
2) ISO Class 7 used to perform hand hygiene and garbing - Anteroom serving HD buffer
room
3)ISO Class 8 used to perform hand hygiene and garbing - Anteroom serving
nonhazardous buffer room
4) Dedicated area into which a PEC is placed - Segregated compounding area
Which of the following tests is not required during certification of secondary engineering
controls? - ANS -- Moisture uniformity testing
Regardless of the type (waist high or full height), only one door of a pass through may
be opened at a time. - ANS -- True
A buffer room has only one LAFW. If the LAFW contributes 10 ACPH to the room, then
what is the minimum ACPH that the room must deliver to meet the USP Chapter 797
requirement? Write the answer numerically. - ANS -- 20
USP 797 (2022) specifies that a minimum of 20 ACPH are required for ISO Class 8
anterooms. - ANS -- True
Which of the following should be AVOIDED in buffer and anteroom designs? More than
one answer is correct, so select all that apply. - ANS -- Cabinets
Exposed pipes under sink
Large door jambs
