USP 825 - MPJE QUESTIONS WITH ANSWERS RATED A+
Personnel that have not performed radiopharmaceutical processing in more than _______ months
must be requalified in all core competencies before resuming duties. - 6
Personnel who perform sterile compounding using a nonsterile drug substances or components
must be requalified in all core competencies every ______ months. - 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. - 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. - 12
What are the only functions that can be performed in an SRPA? - -Sterile radiopharmaceutical
preparation
-Preparation w/minor deviations
-Dispensing
-Repackaging
What is the particle count for ISO Class 3? - 35.2
*Multiply x10 to get the remainder:
ISO Class 4: 352
ISO Class 5: 3,520
ISO Class 6: 35,200
ISO Class 7: 352,000
ISO Class 8: 3,520,000
An LAFW used for preparing radiopharmaceuticals must provide what kind of air flow? -
Vertical and unidirectional
When is it acceptable for a LAFW to provide horizontal and unidirectional airflow? - When the
LAFW is located within the SCA of a hot-cell
Which type of PEC is a cabinet with an open front, inward airflow, downward unidirectional
HEPA-filtered airflow, and HEPA-filtered exhaust? - Biological safety cabinet (BSC) Class II
A minimum of _____ total HEPA-filtered ACPH must be supplied to ISO Class 7 areas. - 30
A minimum of _____ total HEPA-filtered ACPH must be supplied to ISO Class 8 areas. - 20
, (Positive/Negative) pressure minimizes the potential of microbial contamination in sterile drug
preparations areas. - Positive
(Positive/Negative) pressure minimizes the potential radioactive contamination from volatile or
airborne radiopharmaceuticals. - Negative
Positive pressure environments must have a minimum differential positive pressure of _______-
inch water column between each ISO-classified area. - 0.02
T/F: SRPA must be positive pressure compared to unrestricted areas in the presence of volatile
or airborne radiopharmaceuticals. - False, negative pressure
All pressure monitoring devices must be tested for accuracy and required performance at least
every ______ months. - 6
How often must recertification of the PEC and environment in which the PEC is located occur? -
Q6M
How often must viable air sampling of all classified areas be conducted? - Q6M
What is the air sampling action level for ISO Class 5? - >1
What is the air sampling action level for ISO Class 7? - >10
What is the air sampling action level for ISO Class 8? - >100
Surface sampling of all classified areas and all PECs must. be conducted at least ___________
for the detection of microbial contamination. - Monthly
Which type of agent is used for the removal of residues from surfaces? - Cleaning
Which type of agent is a chemical or physical agent used on inanimate surfaces and objects to
destroy fungi, viruses, and bacteria? - Disinfecting
Which type of agent is a chemical or physical agent that destroys bacterial and fungal spores
when used in sufficient concentration for a specified contact time and is expected to kill all
vegetative microorganisms? - Sporicidal
What is the minimum frequency for cleaning, disinfecting and applying a sporicidal of ceilings,
walls, doors, door frames, and storage shelving? - Monthly
How often must hot-cells be cleaned and disinfected? - Daily
How often must the surfaces of sinks be cleaned and disinfected? - Daily
How often must work surfaces outside the PEC be cleaned and disinfected? - Daily
Personnel that have not performed radiopharmaceutical processing in more than _______ months
must be requalified in all core competencies before resuming duties. - 6
Personnel who perform sterile compounding using a nonsterile drug substances or components
must be requalified in all core competencies every ______ months. - 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. - 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. - 12
What are the only functions that can be performed in an SRPA? - -Sterile radiopharmaceutical
preparation
-Preparation w/minor deviations
-Dispensing
-Repackaging
What is the particle count for ISO Class 3? - 35.2
*Multiply x10 to get the remainder:
ISO Class 4: 352
ISO Class 5: 3,520
ISO Class 6: 35,200
ISO Class 7: 352,000
ISO Class 8: 3,520,000
An LAFW used for preparing radiopharmaceuticals must provide what kind of air flow? -
Vertical and unidirectional
When is it acceptable for a LAFW to provide horizontal and unidirectional airflow? - When the
LAFW is located within the SCA of a hot-cell
Which type of PEC is a cabinet with an open front, inward airflow, downward unidirectional
HEPA-filtered airflow, and HEPA-filtered exhaust? - Biological safety cabinet (BSC) Class II
A minimum of _____ total HEPA-filtered ACPH must be supplied to ISO Class 7 areas. - 30
A minimum of _____ total HEPA-filtered ACPH must be supplied to ISO Class 8 areas. - 20
, (Positive/Negative) pressure minimizes the potential of microbial contamination in sterile drug
preparations areas. - Positive
(Positive/Negative) pressure minimizes the potential radioactive contamination from volatile or
airborne radiopharmaceuticals. - Negative
Positive pressure environments must have a minimum differential positive pressure of _______-
inch water column between each ISO-classified area. - 0.02
T/F: SRPA must be positive pressure compared to unrestricted areas in the presence of volatile
or airborne radiopharmaceuticals. - False, negative pressure
All pressure monitoring devices must be tested for accuracy and required performance at least
every ______ months. - 6
How often must recertification of the PEC and environment in which the PEC is located occur? -
Q6M
How often must viable air sampling of all classified areas be conducted? - Q6M
What is the air sampling action level for ISO Class 5? - >1
What is the air sampling action level for ISO Class 7? - >10
What is the air sampling action level for ISO Class 8? - >100
Surface sampling of all classified areas and all PECs must. be conducted at least ___________
for the detection of microbial contamination. - Monthly
Which type of agent is used for the removal of residues from surfaces? - Cleaning
Which type of agent is a chemical or physical agent used on inanimate surfaces and objects to
destroy fungi, viruses, and bacteria? - Disinfecting
Which type of agent is a chemical or physical agent that destroys bacterial and fungal spores
when used in sufficient concentration for a specified contact time and is expected to kill all
vegetative microorganisms? - Sporicidal
What is the minimum frequency for cleaning, disinfecting and applying a sporicidal of ceilings,
walls, doors, door frames, and storage shelving? - Monthly
How often must hot-cells be cleaned and disinfected? - Daily
How often must the surfaces of sinks be cleaned and disinfected? - Daily
How often must work surfaces outside the PEC be cleaned and disinfected? - Daily
