USP 797 Sterile compounding Study guide QUESTIONS WITH
ANSWERS RATED A+
Which clean room environment is preferred for community pharmacies? - vertical airflow
workbench
What is another name for a barrier isolator? - Glove box
Drains or sinks are acceptable in the buffer area as long as they are off to the side. - False
In a sterility test, samples are tested by placing them in growth medium and incubating them for
a minimum of. - 14 days
Which of the following is not caused by the presence of endotoxins in a CSP? - Apathy
Process verification is used to mimic an actual procedure. - False
Annual and routine maintenance reports must remain on file for the lifetime of the equipment. -
True
How long should the LAFW blowers run prior to performing compounding activities? - 30
minutes
CSPs must have a visible auxiliary label. - True
In order to ensure absolute sterility, how many units within a batch need to be tested? - Every
unit
ACD daily performance records should be evaluated once a month. - False
How often should accuracy or precision testing be performed on ACDs? - Once a month
When used regularly, how often should ACDs be calibrated? - Daily
Changes in ACD operations need only be communicate to personnel using the ACDs. - False
The use of ACDs can improve the accuracy and precision) of the compounding process
compared to the traditional manual compounding methods. - True
Only medium and high-risk level compounding require a double-check system before a CSP can
leave the Pharmacy? - False
How often should the pharmacist visually inspect CSPs? - After Compounding
ANSWERS RATED A+
Which clean room environment is preferred for community pharmacies? - vertical airflow
workbench
What is another name for a barrier isolator? - Glove box
Drains or sinks are acceptable in the buffer area as long as they are off to the side. - False
In a sterility test, samples are tested by placing them in growth medium and incubating them for
a minimum of. - 14 days
Which of the following is not caused by the presence of endotoxins in a CSP? - Apathy
Process verification is used to mimic an actual procedure. - False
Annual and routine maintenance reports must remain on file for the lifetime of the equipment. -
True
How long should the LAFW blowers run prior to performing compounding activities? - 30
minutes
CSPs must have a visible auxiliary label. - True
In order to ensure absolute sterility, how many units within a batch need to be tested? - Every
unit
ACD daily performance records should be evaluated once a month. - False
How often should accuracy or precision testing be performed on ACDs? - Once a month
When used regularly, how often should ACDs be calibrated? - Daily
Changes in ACD operations need only be communicate to personnel using the ACDs. - False
The use of ACDs can improve the accuracy and precision) of the compounding process
compared to the traditional manual compounding methods. - True
Only medium and high-risk level compounding require a double-check system before a CSP can
leave the Pharmacy? - False
How often should the pharmacist visually inspect CSPs? - After Compounding
