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