USP 797 Sterile compounding Study
guide 2025 Questions and Answers
Which type of documentation provides general instructions on activities such as
gowning? - ANSWER✔✔-Standard operating procedures
At a minimum, how often should qualified personnel test laminar airflow
workbenches? - ANSWER✔✔-Every six months
If a laminar airflow workbench is turned off between aseptic processing sessions, how
long should it run before it is used? - ANSWER✔✔-30 minutes
Which of the following can be re-worn if properly stored in the anteroom? -
ANSWER✔✔-Gown
Jewelry can be worn in the compounding area as long as the wearer is properly
gowned. - ANSWER✔✔-False
Sterile ingredients, components, devices, and mixtures are exposed to air quality
inferior to ISO Class 5. - ANSWER✔✔-High
Multiple pooled sterile commercial preparations for multiple patients or one patient
multiple times. - ANSWER✔✔-Medium
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, Prepared from non-sterile ingredients. - ANSWER✔✔-High
No bacteriostatic agents are added to the preparation and it is administered over
several days. - ANSWER✔✔-Medium
Compounding occurs in ISO Class 5 (100) environment at all times. - ANSWER✔✔-Low
How often must training be conducted for personnel doing high-risk level
compounding? - ANSWER✔✔-Every 6 months
Who is responsible for ensuring that all compounding personnel are properly trained
and evaluated? - ANSWER✔✔-Pharmacist
Even though training is not completed, it is acceptable for technicians to compound as
long as they are going through training. - ANSWER✔✔-False
What is another name for a media-fill test? - ANSWER✔✔-Broth test
If using an automated compounding device, reports need only be kept for the last three
years. - ANSWER✔✔-False
Which clean room environment is preferred for community pharmacies? -
ANSWER✔✔-vertical airflow workbench
What is another name for a barrier isolator? - ANSWER✔✔-Glove box
Drains or sinks are acceptable in the buffer area as long as they are off to the side. -
ANSWER✔✔-False
COPYRIGHT © 2025 ALL RIGHTS RESERVED
guide 2025 Questions and Answers
Which type of documentation provides general instructions on activities such as
gowning? - ANSWER✔✔-Standard operating procedures
At a minimum, how often should qualified personnel test laminar airflow
workbenches? - ANSWER✔✔-Every six months
If a laminar airflow workbench is turned off between aseptic processing sessions, how
long should it run before it is used? - ANSWER✔✔-30 minutes
Which of the following can be re-worn if properly stored in the anteroom? -
ANSWER✔✔-Gown
Jewelry can be worn in the compounding area as long as the wearer is properly
gowned. - ANSWER✔✔-False
Sterile ingredients, components, devices, and mixtures are exposed to air quality
inferior to ISO Class 5. - ANSWER✔✔-High
Multiple pooled sterile commercial preparations for multiple patients or one patient
multiple times. - ANSWER✔✔-Medium
COPYRIGHT © 2025 ALL RIGHTS RESERVED
, Prepared from non-sterile ingredients. - ANSWER✔✔-High
No bacteriostatic agents are added to the preparation and it is administered over
several days. - ANSWER✔✔-Medium
Compounding occurs in ISO Class 5 (100) environment at all times. - ANSWER✔✔-Low
How often must training be conducted for personnel doing high-risk level
compounding? - ANSWER✔✔-Every 6 months
Who is responsible for ensuring that all compounding personnel are properly trained
and evaluated? - ANSWER✔✔-Pharmacist
Even though training is not completed, it is acceptable for technicians to compound as
long as they are going through training. - ANSWER✔✔-False
What is another name for a media-fill test? - ANSWER✔✔-Broth test
If using an automated compounding device, reports need only be kept for the last three
years. - ANSWER✔✔-False
Which clean room environment is preferred for community pharmacies? -
ANSWER✔✔-vertical airflow workbench
What is another name for a barrier isolator? - ANSWER✔✔-Glove box
Drains or sinks are acceptable in the buffer area as long as they are off to the side. -
ANSWER✔✔-False
COPYRIGHT © 2025 ALL RIGHTS RESERVED
