USP 825 – MPJE EXAM QUESTIONS WITH
100% CORRECT ANSWERS
Which USP chapter deals with the preparation, compounding, dispensing, and
repackaging of radiopharmaceuticals? - ANSWER 825
For compounded preparations involving one or more nonsterile components, a
___________________ procedure must be performed prior to dispensing. -
ANSWER Sterilization
For injectable compounded preparations involving one or more components that
are not certified to be pyrogen-free, ___________________ testing must be
performed prior to dispensing. - ANSWER Bacterial endotoxin
What are 4 different types of shielding? - ANSWER -L-block
-Lead torso
-Vial shield
-Syringe shield
Radiation exposure to personnel is directly proportional to what? - ANSWER -
Quantity of radiation handled
-Time handling the RAM
-Distance of the RAM
Which of the following devices CANNOT be placed inside an ISO Class 5
PEC?
-Dose calibrator
-Monitor
-Bar code scanner
-Glove container
-Label printer - ANSWER Glove container
Successful completion of initial gloved fingertip and thumb sampling is defined
as _______ cfu. - ANSWER 0
, Successful completion of gloved fingertip and thumb sampling after media-fill
testing is defined as _______ cfu. - ANSWER </+ 3
How often must personnel be visually observed while performing hand hygiene,
garbing SOPs, and aseptic technique procedures? - ANSWER Initially &
Q12M
How often must personnel perform fingertip and thumb sampling? - ANSWER
3 times initially & Q12M
How often must personnel conduct a media-fill test? - ANSWER Initially &
Q12M
Personnel that have not performed radiopharmaceutical processing in more than
_______ months must be requalified in all core competencies before resuming
duties. - ANSWER 6
Personnel who perform sterile compounding using a nonsterile drug substances
or components must be requalified in all core competencies every ______
months. - ANSWER 6
T/F: Personnel who are authorized to be within the sterile processing area and
do not handle sterile preparations are still required to complete training on
media-fill testing. - ANSWER False, they are not required to complete training
on media-fill testing but are required. to complete all other training and testing.
Temperature and humidity monitoring devices must be verified for accuracy at
least every ______months or as required by the manufacturer. - ANSWER 12
What are the only functions that can be performed in an SRPA? - ANSWER -
Sterile radiopharmaceutical preparation
-Preparation w/minor deviations
-Dispensing
-Repackaging
What is the particle count for ISO Class 3? - ANSWER 35.2
*Multiply x10 to get the remainder:
100% CORRECT ANSWERS
Which USP chapter deals with the preparation, compounding, dispensing, and
repackaging of radiopharmaceuticals? - ANSWER 825
For compounded preparations involving one or more nonsterile components, a
___________________ procedure must be performed prior to dispensing. -
ANSWER Sterilization
For injectable compounded preparations involving one or more components that
are not certified to be pyrogen-free, ___________________ testing must be
performed prior to dispensing. - ANSWER Bacterial endotoxin
What are 4 different types of shielding? - ANSWER -L-block
-Lead torso
-Vial shield
-Syringe shield
Radiation exposure to personnel is directly proportional to what? - ANSWER -
Quantity of radiation handled
-Time handling the RAM
-Distance of the RAM
Which of the following devices CANNOT be placed inside an ISO Class 5
PEC?
-Dose calibrator
-Monitor
-Bar code scanner
-Glove container
-Label printer - ANSWER Glove container
Successful completion of initial gloved fingertip and thumb sampling is defined
as _______ cfu. - ANSWER 0
, Successful completion of gloved fingertip and thumb sampling after media-fill
testing is defined as _______ cfu. - ANSWER </+ 3
How often must personnel be visually observed while performing hand hygiene,
garbing SOPs, and aseptic technique procedures? - ANSWER Initially &
Q12M
How often must personnel perform fingertip and thumb sampling? - ANSWER
3 times initially & Q12M
How often must personnel conduct a media-fill test? - ANSWER Initially &
Q12M
Personnel that have not performed radiopharmaceutical processing in more than
_______ months must be requalified in all core competencies before resuming
duties. - ANSWER 6
Personnel who perform sterile compounding using a nonsterile drug substances
or components must be requalified in all core competencies every ______
months. - ANSWER 6
T/F: Personnel who are authorized to be within the sterile processing area and
do not handle sterile preparations are still required to complete training on
media-fill testing. - ANSWER False, they are not required to complete training
on media-fill testing but are required. to complete all other training and testing.
Temperature and humidity monitoring devices must be verified for accuracy at
least every ______months or as required by the manufacturer. - ANSWER 12
What are the only functions that can be performed in an SRPA? - ANSWER -
Sterile radiopharmaceutical preparation
-Preparation w/minor deviations
-Dispensing
-Repackaging
What is the particle count for ISO Class 3? - ANSWER 35.2
*Multiply x10 to get the remainder:
